Our client is a publicly traded pharmaceutical company focused on the development and commercialization of novel, once-daily, therapies for the treatment of elevated low-density lipoprotein cholesterol (LDL-C).

Challenge: The client was in the process of completing multiple clinical trials, and they required additional support as they prepared for NDA / MAA submissions.
Redbock Solution: We delivered a team of 18 consultants with a broad range of skill sets including:
<ul>
<li>Statistical Programmers</li>
<li>Clinical Data Managers</li>
<li>Biostatisticians</li>
<li>Clinical Research Associates</li>
<li>Clinical Trial Assistants</li>
<li>Regulatory CMC Consultants</li>
<li>Drug Safety Specialists</li>
</ul>
The team is set-up as a combination of onsite and remote resources, enabling a flexible workforce. Our efficient processes meant we could onboard new resources as quickly as 48 hours from receiving a client request.

Clinical

Our client develops, manufactures, and distributes medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intraoperative monitoring and vascular grafting.

Challenge: Under a Consent Decree related to improvements needed in their Quality System and Medical Device Reporting
Team Size: Delivered a team of over 170 consultants over a period of 5 years
Redbock Solution:
<ul>
<li>Chosen as one of two resource solution firms for this project</li>
<li>Our team reached a maximum of over 60 people working on the project at one point in time</li>
<li>Scaled the team throughout the project based on need with the ability to deliver anywhere from 2-15 resources on-demand</li>
<li>The client received notice from the FDA that it had successfully completed its work plan, thus lifting all shipping restrictions imposed as a term of the 2011 Consent Decree</li>
<li>Deployed team with specialized skill sets including: Computer System Validation Engineers, Process &amp; Production Control Engineers, Manufacturing Engineers, Project Managers, CAPA Engineers, Supplier Quality Engineers, Product Development Engineers, Electrical Engineers, Mechanical Engineers, Training Specialists</li>
<li>Performed gap analysis</li>
<li>Performed equipment qualification testing and verification</li>
<li>Evaluated and Approved TMV Protocols, Reports and Technical Reviews</li>
<li>Provided authorship and execution in IQ, OQ, PQ, TMV, MVP and Validation Trace Matrices</li>
<li>Tool &amp; Fixture design Validation</li>
<li>Performed feasibility &amp; engineering studies</li>
<li>Generated and executed Attribute and Variable Test Method Validation (TMV) Protocols &amp; Reports</li>
<li>Performed statistical analysis on validation data for Gage R&amp;R and % tolerance</li>
<li>Created, maintained, summarized, reviewed, and approved QA related-documentation against quality-document attributes</li>
<li>Performed Readiness/Auditing Review for existing validation documents to determine compliance with current procedures and regulation</li>
<li>Internal and external auditing</li>
<li>Software Quality Assurance review for validation lifecycle documentation for various medical device product families, including: Validation Plan, Change Analysis Form (CAF), Gap Assessments, IQ, OQ, PQ, Periodic Reviews and Summary Reports</li>
<li>Implemented risk-based System Validation, Process Validation and Test Method Validation</li>
<li>Developed documentation for the remediation of Production and Process controls for electro-mechanical surgical equipment and instruments to address action items in the FDA Consent Decree Work Plan</li>
</ul>

Regulatory & Compliance

Our client is a leading pharmaceutical company specializing in developing and commercializing innovative therapies for cancer treatment. With a workforce exceeding 1,000 employees, the organization is committed to advancing scientific R&amp;D and delivering highly effective products to improve patient outcomes.

<h2 class="MsoNormal">The Client</h2>
Our client is a leading pharmaceutical company specializing in developing and commercializing innovative therapies for cancer treatment. With a workforce exceeding 1,000 employees, the organization is committed to advancing scientific R&amp;D and delivering highly effective products to improve patient outcomes. The company&rsquo;s robust pipeline and dedication to regulatory compliance underscore its position as a critical player in the life sciences sector.&nbsp;
<h2 class="MsoNormal">The Challenge</h2>
The client&rsquo;s challenge stemmed from needing additional specialized quality expertise and support, sooner than traditional employees could be identified and hired.&nbsp;
The client engaged Redbock for our dedicated consulting services.&nbsp; 
<h2 class="MsoNormal">Redbock Solution</h2>
Redbock implemented a structured approach to sourcing consultants for the project. Our business development team collaborated with the client to outline specific requirements, objectives, and deliverables, which guided the fulfillment team&rsquo;s selection process. 
We assigned specialized members of the fulfillment team to focus on sourcing consultants that met the client&rsquo;s needs by reviewing current consultant profiles, leveraging professional networks, and actively seeking additional professionals as contenders. After the fulfillment team interviewed and screened qualified professionals, the business development representative evaluated the finalists and decided who would proceed to discussions with the client.
Once the final selected consultants were agreed upon, we prepared and executed the statement of work (SOW) and necessary contract paperwork. Background checks were conducted to ensure compliance with Redbock and client policies and ensure the consultants were ready to begin by the agreed-upon start dates.&nbsp;
<h2 class="MsoNormal">Outcomes</h2>
We successfully deployed a qualified team with specialized experience in very particular aspects of the pharmaceutical industry and quality systems compliance. 
Over the span of just one year, we deployed 11 consultants in critical roles, improving the operational capacity of the client&rsquo;s quality organization. 
The roles filled comprised a range of responsibilities, including:
<ul style="margin-top: 0cm;" type="disc">
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Clinical Quality Management</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Auditing and Audit Support</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Document Archivist</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">GxP Training Development</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Batch Record Review</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Quality Documentation</li>
</ul>
<hr>
<h2 style="margin-bottom: 0cm; margin-top: 0cm;">Improve Your Quality Standards with Redbock's Consulting Services</h2>
This case illustrates the successful deployment of skilled consultants and highlights the importance of strategic resourcing solutions in improving operational effectiveness and ensuring regulatory and quality compliance within the life sciences industries. Are you looking to benefit from our comprehensive <a href="https://redbock.com/expertise/quality/">quality consulting services</a>?
At Redbock, our team of skilled consultants specializes in helping your pharmaceutical, biotech, medical device and diagnostics projects meet the highest quality and compliance standards. Our consultants&rsquo; expertise includes&nbsp; GxP training, compliance and auditing, validation, quality control, quality engineering, quality systems development, implementation and compliance, and more.&nbsp; Redbock provides comprehensive support tailored to your business needs. <a href="https://redbock.com/contact/">Partner with Redbock today.</a>&nbsp;

Quality

Our client is a prominent global medical technology company committed to addressing significant health challenges communities face worldwide. Their strategic R&amp;D investments enable the creation of innovative medical devices and therapies that positively impact the lives of millions.

<h2>The Client</h2>
Our client is a prominent global medical technology company committed to addressing significant health challenges communities face worldwide. Their strategic R&amp;D investments enable the creation of innovative medical devices and therapies that positively impact the lives of millions. The client's comprehensive portfolio includes cardiovascular health, diabetes management, neuroscience, and medical-surgical applications.
<h2 class="MsoNormal">The Challenge</h2>
The client sought Redbock's expertise to oversee the acquisition and integration of a new manufacturing site dedicated to producing sterile barrier packaged ECMO medical devices using injection molding manufacturing technology. The project required sourcing highly specialized engineering professionals in a challenging remote location.
Competing against more than 10 engineering-specific suppliers, we were selected by the client primarily due to our demonstrated expertise and ability to identify hard-to-source profiles swiftly. We were recognized for our capacity to provide a comprehensive, team-oriented turnkey solution for the manufacturing facility, which required consultants to work entirely on-site.
<h2 class="MsoNormal">Redbock Solution</h2>
Each role was tasked with supporting 15 new engineering projects focused on capital equipment and the handling of day-to-day operational quality activities. These projects included new process and equipment validations, new process implementation, process improvements/operational excellence initiatives, corrective and preventive action (CAPA) reviews, and identifying new component vendors.
We deployed a team of dedicated recruiters who focused solely on identifying resources for this project. After quickly exhausting the available local resources, Redbock ensured success by strategically targeting candidates who were willing to temporarily relocate and work on-site in a remote location. We identified and recruited candidates from various regions across the country, many of whom relocated to contribute to the site&rsquo;s corporate integration efforts, overall process modernization, and operational improvements. This strategic approach ensured the timely completion of the project goals.
We successfully deployed 11 consultants to support this critical initiative, primarily in engineering roles, including: 
<ul style="margin-top: 0cm;" type="disc">
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">4 x Senior Quality Engineers (Sr. QEs) - 3 Operational Quality Engineers and a Quality Engineer focused on tooling/molding equipment upgrades and supplier quality (Production Part Approval Process - PPAP) activities</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Principal Quality Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">2 x Senior Manufacturing Engineers</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Senior Packaging Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Project Manager - Multidisciplinary Engineering</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Labeling Specifications Specialist (Quality Systems Integration activities)</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Quality Engineering Technician</li>
</ul>
<h2 style="margin-bottom: 0cm; margin-top: 0cm;">Our Partnership</h2>
&nbsp;
Following the success of this project, Redbock was given additional scope with the client, particularly within the engineering group, engaging in several other initiatives that contributed to our overall collaboration. 
&nbsp;
Common roles we support in the engineering space for this client:
&nbsp;
<ul style="margin-top: 0cm;" type="disc">
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Quality Engineering Technician</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Senior Quality Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Principal Quality Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Senior Product Development Project Management Specialist</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Principal Product Development Project Management Specialist</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Senior Manufacturing Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Principal Firmware Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Project Manager - Multidisciplinary Engineering</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Senior Packaging Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Senior Engineering Project Manager</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Engineering Program Manager</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Principal Software Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Senior R&amp;D Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Sr. Process Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Sr. Reliability Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Sr. Systems Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Sr. Human Factors Design Engineer</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">Product Engineer II</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l0 level1 lfo1;">R&amp;D Engineer II</li>
</ul>
<hr>
<h2>Expert Consulting Services for Life Science Leaders</h2>
At Redbock, we specialize in delivering qualified professionals to improve your engineering operations. Our consultants possess expertise in project management, procurement, and quality assurance, all provided through our comprehensive <a href="https://redbock.com/expertise/engineering/">engineering consulting services</a>. We facilitate connections with the foremost engineering specialists in the life sciences sector. By understanding our clients' value propositions, we expedite project execution efficiently and precisely.
Do you need to secure skilled engineering personnel for your business? <a href="https://redbock.com/contact/">Contact us today and share your requirements to get started</a>.

Engineering

Our client is a world leader in biotechnology, developing and commercializing innovative biopharmaceuticals for rare diseases driven by genetic causes.

<h2>The Client</h2>
Our client is a world leader in biotechnology, developing and commercializing innovative biopharmaceuticals for rare diseases driven by genetic causes.
<h2 class="MsoNormal">The Challenge</h2>
In response to a significant upsurge in workload demand and the non-performance of an existing partner, the client sought to augment its biometrics capabilities. The objective was to integrate a dedicated Biometrics FSP (Functional Service Provider) partner with specialized expertise to support multiple studies. The client required a comprehensive team of biometrics consultants to ensure the integrity of their operations.
<h2 class="MsoNormal">Redbock Solution</h2>
By applying our extensive knowledge of the biometrics industry and understanding our clients' needs, we engaged a diverse group of expert consultants through an FSP model.&nbsp;
Through this model, we provided individual resources with extensive experience and specialized skills to support our clients' teams in-house resources. This arrangement was designed to assist with both short and long-term projects, to fill any resourcing gaps, or to offer in-house oversight for outsourced work.&nbsp;
This model served as an extension of our client's in-house teams, with FSP resources directly interacting with managerial stakeholders while using the client's internal systems and SOPs.
Each consultant possessed specialized skills tailored to address the complex requirements of our client&rsquo;s projects. They included:
<ul style="margin-top: 0cm;" type="disc">
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l1 level1 lfo1;">Statistical Programmers</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l1 level1 lfo1;">Clinical Data Managers</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l1 level1 lfo1;">Biostatisticians (US and UK)</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l1 level1 lfo1;">Data Scientists</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l1 level1 lfo1;">Application Developers/R Programmers</li>
</ul>
Our ability to scale up or down as needed allowed the client to utilize Redbock's services for fluctuating workload. 
&nbsp;
In addition to our core FSP offerings, Redbock provided an array of other expertise and resources for the client:
&nbsp;
<ul style="margin-top: 0cm;" type="disc">
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l1 level1 lfo1;"> Remote Consultant Setup: We supplied equipment and resources for setting up consultants remotely, ensuring seamless integration regardless of geographical barriers.</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l1 level1 lfo1;">Dedicated Account Management: We provided dedicated account management services, including a relationship manager, a reliable operations point of contact and a proficient delivery team.</li>
<li class="MsoNormal" style="margin-bottom: 0cm; margin-top: 0cm; mso-margin-bottom-alt: 8.0pt; mso-margin-top-alt: 0cm; mso-add-space: auto; mso-list: l1 level1 lfo1;"> Fast Deployment: Upon receipt of a new FSP resource request, we provided shortlisted resources within 24-48 hours and started a new FSP resource within two weeks, minimizing disruption to ongoing projects.</li>
</ul>
<h2 class="MsoNormal">Outcomes</h2>
Redbock has served as the client's strategic partner for over five years, providing more than 45 highly qualified consultants. Given the success of our collaboration within the Biometrics function, Redbock is now expanding its service offerings to encompass other functions, such as Regulatory and Clinical Operations.
<hr>
<h2 class="MsoNormal">Do You Require FSP or Biometrics Consulting Solutions?</h2>
If your organization is facing challenges in sourcing highly qualified personnel for clinical and biometrics projects, Redbock is here to partner with you by offering expert <a href="https://redbock.com/expertise/clinical/">biometrics consulting solutions</a>. With over 24 years of global resourcing experience, we are well-positioned to deliver skilled, discipline-specific consultants essential for your long-term business success.
We work closely with industry consultants to deliver comprehensive solutions for biostatistics, statistical programming, clinical data management, clinical operations, pharmacovigilance, and related fields, helping you build the team you need.
<a href="https://redbock.com/contact/">Partner with us today</a> to connect with skilled, like-minded professionals in the life science industry who can drive impactful results in your clinical studies.
&nbsp;

Biometrics

Challenge: The client was in the process of completing multiple clinical trials, and they required additional support as they prepared for NDA / MAA submissions. Redbock Solution: We delivered a team of 18 consultants with a broad range of skill sets including: <ul> <li>Statistical Programmers</li> <li>Clinical Data Managers</li> <li>Biostatisticians</li> <li>Clinical Research Associates</li> <li>Clinical Trial Assistants</li> <li>Regulatory CMC Consultants</li> <li>Drug Safety Specialists</li> </ul> The team is set-up as a combination of onsite and remote resources, enabling a flexible workforce. Our efficient processes meant we could onboard new resources as quickly as 48 hours from receiving a client request.

Challenge: The client was in the process of developing and manufacturing a cardiopulmonary device and they required additional support on the design and development of the new product. Redbock Solution: <ul> <li>Chosen as a strategic partner for this project, Redbock delivered a team of consultants with a broad range of product development expertise, including: <ul> <li>Mechanical Engineers</li> <li>Electrical Engineers</li> <li>Systems engineers</li> </ul> </li> <li>16 consultants supported these efforts over the last year.</li> <li>Deployed a team of consultants with a specialized skill set and experience in: New Product Development, Medical Device, Mechanical parts, Centrifugal pumps, Fluidics, Gas systems, EPGS, etc.</li> <li>Utilized engineering skills to solve engineering problems at the component through system level.</li> <li>Conducted testing utilizing existing test protocols or developing new ones as needed.</li> <li>Redbock Consultants worked in various functional areas to develop new products, coordinate the introduction of new products, and improvements of existing products and processes.</li> <li>Redbock Consultants contributed to the intellectual property position of the client via invention and patent applications.</li> <li>Redbock Consultants followed design control procedures for proper development and control of design plans, design documents and specifications, protocols, results, etc. </li> <li>Redbock Consultants provided technical assistance and leadership required to plan and implement specific projects to be completed, including organizing and leading members of various departments, planning, scheduling, and coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, in a manner consistent with the company objectives.</li> </ul> The team is set-up to start working remotely but will be required to be onsite when the client returns to the office.

Challenge: The client was quickly growing and needed additional support as they prepared for several filings and their first drug approval. After receiving approval there was an immediate need for QMS, Risk Management, QA Packaging, Auditing, SOP development and GCP/GMP support. Team Size: Redbock immediately delivered a team of over 6 consultants who supported the client for a 6-12 month period. Redbock Solution: <ul> <li>Chosen as the only resource solution firm for this project and is now the go to provider for other functional groups at this company</li> <li>Scaled the team throughout the project based on need with the ability to deliver anywhere from 2-10 resources on-demand</li> <li>Created, maintained, summarized, reviewed, and approved QA related-documentation against quality-document attributes</li> <li>Performed readiness/auditing review for existing quality documents to determine compliance with current procedures and regulations</li> <li>Provided vendor management, contract processing, quality agreements maintenance and helped to develop vendor performance metrics </li> <li>Managed internal and external audit programs including identification of auditors, service providers, management of audit schedule and reports</li> <li>Oversaw and performed quality audits; GMP, GCP, GVP, GDP, GLP</li> <li>Provided QA packaging operations support for a commercial activities; transportation validation, third party logistics procedures/audits, sterilization, packaging validation and established GMP and Good Distribution Practice procedures</li> <li>Provided risk management support and helped to facilitate the creation of; quality risk management plans & policies, SOP creation (GMP, GCP) risk assessments, maintain risk logs/metrics, project management of mitigations to completion and helped to identify /assess mitigations for compliance.</li> <li>Provided executed batch record review from our client’s drug substance manufacturer. Activities included review of analytical data packages, purity and potency of the product, physicochemical and biological analysis for characterization, comparability studies, oversight of essential documents (protocols, deviations, informed consent, investigator brochure, investigator site audits).</li> </ul>

Challenge: Under a Consent Decree related to improvements needed in their Quality System and Medical Device Reporting Team Size: Delivered a team of over 170 consultants over a period of 5 years Redbock Solution: <ul> <li>Chosen as one of two resource solution firms for this project</li> <li>Our team reached a maximum of over 60 people working on the project at one point in time</li> <li>Scaled the team throughout the project based on need with the ability to deliver anywhere from 2-15 resources on-demand</li> <li>The client received notice from the FDA that it had successfully completed its work plan, thus lifting all shipping restrictions imposed as a term of the 2011 Consent Decree</li> <li>Deployed team with specialized skill sets including: Computer System Validation Engineers, Process & Production Control Engineers, Manufacturing Engineers, Project Managers, CAPA Engineers, Supplier Quality Engineers, Product Development Engineers, Electrical Engineers, Mechanical Engineers, Training Specialists</li> <li>Performed gap analysis</li> <li>Performed equipment qualification testing and verification</li> <li>Evaluated and Approved TMV Protocols, Reports and Technical Reviews</li> <li>Provided authorship and execution in IQ, OQ, PQ, TMV, MVP and Validation Trace Matrices</li> <li>Tool & Fixture design Validation</li> <li>Performed feasibility & engineering studies</li> <li>Generated and executed Attribute and Variable Test Method Validation (TMV) Protocols & Reports</li> <li>Performed statistical analysis on validation data for Gage R&R and % tolerance</li> <li>Created, maintained, summarized, reviewed, and approved QA related-documentation against quality-document attributes</li> <li>Performed Readiness/Auditing Review for existing validation documents to determine compliance with current procedures and regulation</li> <li>Internal and external auditing</li> <li>Software Quality Assurance review for validation lifecycle documentation for various medical device product families, including: Validation Plan, Change Analysis Form (CAF), Gap Assessments, IQ, OQ, PQ, Periodic Reviews and Summary Reports</li> <li>Implemented risk-based System Validation, Process Validation and Test Method Validation </li> <li>Developed documentation for the remediation of Production and Process controls for electro-mechanical surgical equipment and instruments to address action items in the FDA Consent Decree Work Plan</li> </ul>

We are not just filling a resource requirement, we are curating a positive, results-driven experience - taking the hassle and frustration out of the job search and hiring alike. Everything we do is defined by relationships; every person we hire, every team we build, and every solution we create helps build connections between our clients and consultants.
Our comprehensive candidate selection process ensures that clients are only matched with the top professionals in their area of expertise, while our high caliber, solution-based service offers new possibilities and insights into where our clients can venture.
Redbock will keep your Life Science business on track
Every day, companies lose sight of their mission because they're bogged down by day-to-day tasks and internal issues. But what if you could delegate those areas of work to highly qualified consultants whose sole intention is to help alleviate your workload? That's the premise behind Redbock&mdash; creating opportunities for people to do the work that matters.

<h2>We help connect people in need</h2>

<h2>Our Core Pillars</h2>

<h4>Remaining Competitive within the Clinical Research market</h4> Clinical Research is one of the most exciting and complicated parts of the Life Science sector and there has never been a more crucial time to engage a trusted consultancy partner to help you navigate this exponentially evolving terrain. In the wake of the pandemic, companies are continuing to recover from the disruption and vaccination trials are now on the rise. Other disruptive trends include the rise of personalized medicines and the rapidly growing markets of expanded access and post-trial monitoring, with an influx of sponsorship evident in these areas. The rapid increase the industry is experiencing in remote trials has had great consequence on the traditional clinical trial supply chain and simultaneously enhanced the geographical potential for many business operations, while also complicating their internal processes. We recognize the variables associated with conducting a Clinical development program, including the specific phase of development, the targeted therapeutic area and the types of studies being conducted. To remain viable in this thriving yet competitive sector, it is imperative to have access to specialist skillsets with an in-depth understanding of your subject matter, and a sincere appreciation for your corporate mission. Our ability to pair businesses with like-minded professionals means the placements we make are sustainable, thereby promoting loyalty for future operational growth.

<h4>Sourcing highly qualified personnel for your Clinical Research projects</h4> We work alongside FDA-regulated companies that are researching and developing new products and provide them with the expertise needed to get their drugs, biologics or devices to market. Our candidate management system has been developed to align with the demands of the industry, meaning we can quickly segment our networks and refine our search by organizational type, therapeutic area experience, types of studies, phases worked in and experience level. <div className="bg_light p-4 genCon mt-5"> Our solutions cover strategic areas which include: <ul> <li>Clinical Research and Trials</li> <li>Biostatistics</li> <li>Statistical Programming</li> <li>Data Management</li> <li>Pharmacovigilance</li> <li>Drug Safety</li> <li>Regulatory Affairs</li> </ul>

<h4>Recognizing Engineering needs for the Life Sciences market</h4> The drivers disrupting the Engineering space have manifested a number of changes in the production landscape, including an increased number of automation and technology-controlled manufacturing processes, and a huge increase in the number of new biologics manufacturing sites being commissioned. As more manufacturing sites are operational than ever before, the volume of talent required is unprecedented and we understand the mounting pressures you face to maintain optimal business output. The higher complexity within the biologics production process in particular, invariably demands a more complex construction project, requiring greater manpower to execute the scope. This has resulted in a number of large-scale site builds, significantly draining the available candidate pool. Our expert teams keep up-to-date with competing projects, understand our clients' employee value propositions, and are able to offer support on how to position projects and vacancies to compete for the best talent.

<h4>Securing Engineering Personnel for your Business</h4> We manage our consultant network with industry-leading technology, which ensures our engineering connections are perpetually expanding, and that we can communicate with professionals in a very short timeframe. We consistently engage consultants with leadership and specialist capabilities across all aspects of Engineering. <div className="bg_light p-4 mt-5 genCon"> We will deliver qualified professionals to enhance your engineering operation, including those with experience in: <ul> <li>Automation and Computer Systems Validation (CSV)</li> <li>Calibration</li> <li>Construction Management / Scheduling</li> <li>Installation Qualification</li> <li>Operating Specialists, Operational Qualification</li> <li>Process Engineering & Qualification</li> <li>Procurement</li> <li>Project Management, Manufacturing Supervisors & Shift Team Leaders</li> <li>Quality</li> </ul>

<h4>Considerations within your Quality department</h4> Quality Assurance is a critical part of any Life Science eco-system in ensuring that the research, development, production, and maintenance of products meet applicable regulations, and are optimized for user safety, transparency, and consistency. Significant investment into the Life Sciences Quality space, coupled with the advances in innovation driving clinical development pipelines forward, necessitate that employers secure increasingly specific levels of specialization in their expertise. We recognize that there is increasing strain on the quality talent pool and that competition is fierce. Many organizations are adopting a “total quality” approach to enable all facets of their quality considerations to be managed as a single harmonized process, significantly impacting the talent supply chain for many organizations.

<h4>Sourcing personnel for your Quality Assurance and Control team</h4> Our broad consultant network is equipped to supply specialists for every part of your quality management system. We will tap into the active and passive market and exercise a compelling brand story on your behalf to attract consultants from far and wide to their dream Quality job. Our consultants develop and implement internal processes to ensure that your company’s systems run seamlessly through writing and executing standard operating procedures and performing batch record reviews; developing and implementing quality systems; planning and resolving corrective and preventative actions (CAPAs) and evaluating / executing quality control. Through a commitment to nurturing the Quality market, we ensure that our consultants embody a technical competency, analytical mindset and demonstrable proficiency in keeping up to date with changing legislation to keep your business compliant. Our consultants’ experience levels range from entry-level to those with the capacity to lead an entire Quality function, encompassing quality execution, automation, management & auditing, systems validation, remediation and production approvals into their remit. <div className="bg_light p-4 genCon mt-5"> Examples of Quality specialists provided: <ul> <li>Quality Auditors</li> <li>Quality Engineers</li> <li>Quality Managers / Directors</li> <li>Head of Quality</li> <li>Validation Managers</li> <li>Specialists in Automation / CSV / QMS / Quality Control / Remediation / Supplier Management</li>

We place professionals with diligent focus on the discovery, testing, manufacturing and marketing of your products, including those with experience in: <ul> <li>Chemistry, Manufacturing, and Controls (CMC)</li> <li>Good Manufacturing Practices (GMP)</li> <li>Good Clinical Research Practise (GCP)</li> <li>Post Approval & Maintenance</li> <li>Regulatory Affairs Management</li> <li>Submissions</li> </ul>

<h4>Building a Regulatory & Compliance team to navigate the changing Life Sciences landscape</h4> Regulatory Affairs functions are critical to ensuring safe products are delivered to market and are therefore paramount to the success of your business. The rapid increase in project numbers means that many Regulatory Affairs skillsets are in acute demand for businesses striving to build teams with experience in new market authorizations, new product approvals, regulatory CMC, orphan indications and specialty pharma. We recognize the multitude of complexities you must consider when building your Regulatory Affairs department. The positions are technical and varied, often requiring a high degree of specialization with contrasting variables such as regional focus, type of therapy, stage of development or approval of the therapy, and therapeutic area. Often the regulatory operation must navigate multiple contrasting legislations, whether related to drug manufacturing, export laws or advertising restrictions – a task which is further complicated by the addition of affiliates across local and global remits. We will deliver the right personnel to ensure that your Regulatory Affairs team will get your therapy or product to market and keep it there, while drastically expanding patient access and sales pipelines.

<h4>Securing Regulatory & Compliance personnel for your business</h4> Our experts conduct audits, perform 483 observations and remediation, provide consent decree resolution, coordinate regulatory filings (IND, NDA, 510k, and PMA), and are suitably equipped to manage complaint handling and medical device reporting. </div> <div className="bg_light p-4 genCon"> We place professionals with diligent focus on the discovery, testing, manufacturing and marketing of your products, including those with experience in: <ul> <li>Chemistry, Manufacturing, and Controls (CMC)</li> <li>Good Manufacturing Practices (GMP)</li> <li>Good Clinical Research Practise (GCP)</li> <li>Post Approval & Maintenance</li> <li>Regulatory Affairs Management</li> <li>Submissions</li> </ul>

<h4>Quality</h4>
Optimize productivity and meet project requirements every time. Our specialized consultants make sure your systems run seamlessly by developing and executing standard operating procedures, batch record reviews, quality systems, corrective and preventative actions, and quality control.
<h4>Regulatory &amp; Compliance</h4>
Well-versed in the industry's regulated environments, our consultants ensure every project meets required legislation. In addition to managing complaint and medical device reporting, they perform GMP/GCP auditing and FDA 483 observations for quality remediation plans, and provide consent decree resolution and regulatory filings, including IND, NDA, 510k, and PMA.
<h4>Engineering</h4>
Our software, mechanical, and electrical engineers provide reliable, specialized support. They are responsible for designing, developing, testing, and deploying products, systems, applications, and equipment. Their expertise also covers validating equipment, processes, software, and cleaning systems.
<h4>Clinical</h4>
Get drugs, biologics, and devices to the market, quickly. We provide support throughout the entire clinical trial process. Our solutions for FDA regulated companies cover clinical research, biostatistics, statistical programming, data management, pharmacovigilance/drug safety and medical writing.

<h1>Leading the Life Science Consulting Category</h1>

Expertise

<h1>Positive Impact starts with the Right Partnership</h1>
We provide resourcing solutions and highly skilled consultants to pharmaceutical, biotech, medical device and diagnostics companies.

Not having the resources, time, and budget to succeed can have lasting effects on your business. More importantly, it can keep you from developing life-saving products and therapies. We match your business with expert consultants and customized resource teams, partnering with you for long-term success. Work with us to solve critical issues, drive products to market, and produce solutions that positively impact lives.

<h2>The Right Resources Make A Difference</h2>

<h1>Positive Impact starts with the Right Partnership</h1>We provide resourcing solutions and highly skilled consultants to pharmaceutical, biotech, and medical device companies

We have worked with the world's leading life science companies, and what makes us stand out is our commitment to integrity, relationships, and results you can count on. We are here whenever you need us, because to us, this is more than work. Our solutions help make life better for all.

<h3>Twenty four Years of Global Resourcing Experience</h3>

We work exclusively with consultants who specialize in the life science industry, so you will get the best solution for your needs every time. Our rigorous selection process ensures you're matched with the top professionals in their area of expertise.

<h3>Custom Solutions with Subject Matter Experts</h3>

<h2>A Reputation of Integrity and Commitment</h2>

Market leading insights in resourcing solutions

Redbock provides resourcing solutions and highly skilled consultants to pharmaceutical, biotech, and medical device companies. Based in Encinitas, California, we work exclusively within the Life Science industry and have helped some of the world&rsquo;s largest and most cutting-edge companies through providing expert consultants and customized resource teams.
OUR MISSION: To provide expert solutions to resource-challenged companies, and to positively impact lives through our work. With over 24 years of experience, the Redbock strategy is to partner with our clients for long-term success so they can continue to improve the healthcare market by developing life-saving products and therapies.
<h4>Redbock's History</h4>
Redbock is built upon a strong foundation. It is our utmost belief that if a foundation is not laid correctly, everything built upon it will be weak and eventually fail. That is why we created our company on the only element that sustains and grows business during resource-challenged times: people.
In June 2018, Redbock was acquired by NES Fircroft, a world-leading technical workforce solutions provider with 100 offices situated across the globe garnered from over 50 years of industry experience. Our combined resources give Redbock access to international finance, legal, compliance and support teams, strengthening our capacity to access global resources and deploy them quickly.

Case Studies

Clinical

Regulatory & Compliance

Quality

Engineering

Biometrics