SERVICES

Areas of Expertise

Quality

Our quality consultants develop and implement internal processes to ensure that your company’s systems are running seamlessly. They write and execute Standard Operating Procedures (SOPs) and perform Batch Record Reviews; develop and implement Quality Systems; plan and resolve Corrective and Preventative Actions (CAPAs); evaluate and execute Quality Control.

Engineering

Our engineering team consists of software engineers, mechanical engineers, and electrical engineers — responsible for designing, developing, testing, and deploying products, systems, applications, and equipment. The consultants on this team also have expertise validating equipment, processes, software, and cleaning systems.

Regulatory/Compliance

Our regulatory and compliance consultants conduct GMP/GCP Auditing, perform 483 Observations and Remediation, provide Consent Decree Resolution, and coordinate Regulatory Filings (IND, NDA, 510k, and PMA). The team also manages complaint handling and medical device reporting.

Clinical

We work alongside FDA regulated companies that are researching and developing new products and providing them with the expertise needed to get their drugs, biologics or devices to market. Our solutions cover strategic areas which include: Clinical Research, Biostatistics, Statistical Programming, Data Management, Pharmacovigilance/Drug Safety and Regulatory Affairs.

Services

Case Studies

MEDICAL DEVICE MANUFACTURER

Client: A $15B medical device manufacturer and supplier of cardiovascular health products
Issue: Under a Consent Decree related to improvements needed in their Quality System and Medical Device Reporting

Redbock Solution:

  • Deployed a team with specialized skill sets: Project Managers, CAPA Engineers, Supplier Quality Engineers, Product Development Engineers, Electrical Engineers, Process & Production Control Engineers, Computer System Validation Engineers, Manufacturing Engineers, Mechanical Engineers, Training Specialists
  • The client received notice from the FDA that it had successfully completed its work plan. As a result, all shipping restrictions imposed as a term of the 2011 Consent Decree were lifted

engineer-2

MEDICAL DEVICE MANUFACTURER

Client: A $25B medical device manufacturer and supplier of dental restorative health products
Issue: Received warning letters related to improvements needed in their manufacturing process

Redbock Solution:

  • Deployed a team with specialized skill sets: Quality
    Engineers, Manufacturing Engineers, CAPA Engineers,
    Supplier Quality Engineers and R&D Engineers
  • The project is still on-going with gaps and inefficiencies
    in their process being identified and rectified
I was very drawn to Redbock as it aids in my professional development, as well as the beginning of a long lasting relationship for the years to come. I can say that I am grateful for lining up with a company of such caliber with underlying values, ideals, honor and integrity as this is what I feel from afar while on assignment.
David L.
David L.
Redbock Consultant
Redbock was able to help us work through a consent decree by addressing corrective actions needed with our quality systems and process controls. The interaction that we had with them was extremely smooth – from initial conversation, through signing of the contracts, to delivery of services – they managed our project with the highest level of integrity. We prefer to use Redbock and I would highly recommend using them for your projects.
Susan
Susan
Medical Device Client
I find that I have been fortunate throughout my life for many reasons. One of the blessings has been the recognition of great opportunities to meet and walk along the path with some great people. You being the prime example of those great people and Redbock being the great opportunity. I am grateful to have met you and have enjoyed the gifts of your wisdom, friendship and fellowship. Thank you for the opportunity to be a part of Redbock.
David N.
David N.
Redbock Consultant
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