Regulatory Operations
Successful regulatory filings are crucial to enable a clinical research program. High quality submissions can speed up development timelines which ultimately lead to faster time to market, expedited delivery of new treatments to patients, and optimizing your research investments. We can prepare and manage your new regulatory applications and follow-on submissions with experience and precision.
Our services include:
Management of pre-IND and other regulatory meetings
Preparation of regulatory briefing packages
Preparation and submission of INDs, CTX/CTAs, CTNs and other applications
Management of follow-on IND submissions (Amendments, Annual Reports, etc.)
Serve as primary contact with regulatory agencies
Set up and manage regulatory document control systems and database