MedSource Regulatory Affairs Management Services

At MedSource, the regulatory affairs department is comprised of a diverse group of highly trained and knowledgeable professionals who provide first-rate support to the clinical operations department and corporate activities. The team of regulatory affairs managers and specialists are responsible for performing a variety of functions for both internal and external clients, all with an eye for maintaining strict compliance with applicable regulations.

The regulatory affairs department provides the following services:

• Prepare and manage regulatory applications and submissions
• Ensure proper implementation of industry regulations and guidance documents
• Evaluate and review project-related materials for conformance to current regulations and guidelines
• Oversee regulatory document creation, dissemination, and collection during study start-up
• Receive, review, file, and maintain study-related essential documentation
• Create, evaluate, and review informed consent templates
• Prepare and submit essential documents to IRBs and investigative sites
• Report serious adverse events to regulatory agencies and investigative sites
• Create and customize study-specific filing systems, regulatory document tracking tools, and archive files
• Perform Quality Assurance file audits, site audits, and vendor audits
• Manage third-party vendors
• Create and implement Standard Operating Procedures and Working Practice Guidelines