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Regulatory Affairs Management

Our diverse, knowledgeable and highly trained professionals provide first-rate support to clinical operations and corporate activities. This team performs a variety of functions for both internal and external clients, maintaining strict compliance with all applicable regulations.

Services include:
  • Prepare and manage regulatory applications and submissions
  • Properly implement, evaluate and review for adherence to industry regulations and guidelines
  • Oversee regulatory document creation, dissemination, and collection during study start-up
  • Receive, review, file, and maintain essential documentation
  • Create, evaluate, and review informed consent templates
  • Report serious adverse events
  • Customize study-specific filing systems, regulatory document tracking tools, and archive files
  • Perform quality assurance audits
  • Manage third-party vendors
  • Create and implement standard operating procedures and working practice guidelines