With nearly two decades navigating the FDA regulatory process, ClinicalRM has experts in human subjects protection, dozens of staff who have served on IRB boards, clinical writers who specialize in streamlining and complying with the regulatory process, and a large pool of Program/Project Managers who know how to design protocols and plans to meet the myriad of regulatory requirements (FDA, GLP, GCP, GMP, QSR, CFR 21Part 11).
ClinicalRM regulatory experts create protocols that can be finalized quickly and supported by sites so that studies run on time or even ahead of schedule. We provide investigational new drug (IND) and new drug application (NDA) support and guide the client through each step of the process: providing expert advice, planning meetings, preparing pre-meeting briefing packages, and facilitating communication with regulatory agencies.
ClinicalRM can review and evaluate your pre-clinical data and essential site documents, provide support and prepare materials for FDA meetings, maintain your master files, and as always, provide our expert advice. In addition, we can submit your FDA Regulatory documents, including:
- Investigational New Drug (IND) / Investigational Device Exemption (IDE)
- New Drug Application (NDA)
- 510(k) Clearance and Premarket Approval Process and Documentation
- Biologics License Application (BLA)
- Premarket Approval (PMA) / Product Development Protocol (PDP)