Securing Regulatory & Compliance personnel for your business
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.
We provide expert resources with diligent focus on the discovery, testing, manufacturing and marketing of your products, including those with experience in:
- Chemistry, Manufacturing, and Controls (CMC)
- Good Manufacturing Practices (GMP)
- Good Clinical Research Practise (GCP)
- Post Approval & Maintenance
- Regulatory Affairs Management
- Submissions
Regulatory & Compliance Consulting Services
Building a Regulatory & Compliance team to navigate the changing Life Sciences landscape
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.
