Regulatory Strategy and Interactions
As the global regulatory environment continues to evolve, with increasing emphasis on risk management, safety surveillance, and post-approval study requirements, REGISTRAT-MAPI has experienced professionals to guide you through the complex process of product registration. We collaborate with clients to strategically design peri- and post-approval programs to satisfy FDA, EMEA, and other regulatory agency requirements for safety and risk mitigation while simultaneously supporting important clinical and commercial interests of the company.
REGISTRAT-MAPI provides regulatory consulting to:
- Review the overall regulatory submission strategy and help define an integrated approach to risk management
- Provide regulatory liaison support and interaction (e.g., preparation, meetings, and responses to regulatory authorities)
- Develop an integrated risk management plan to address the requirements of various regulatory authorities
- Strategically design post-marketing requirement studies to address product safety and other important company interests
- Design and implement “bridging studies” prior to product approval (e.g., expanded access, safety extension, registries, Phase IIIb, large streamlined trials)
- Evaluate emerging safety signals
- Develop a pharmacovigilance plan
- Provide clinical, epidemiology, biostatistics, and analytical support