The path to Regulatory approval is full of pitfalls. Let our expert consultants who are familiar with the journey guide you and decrease the possibility of regulatory rejection.
- Conduct hands on PK, PK/PD, POP PK analysis
- Conduct due-diligence and in-licensing activities
- Serve as your clinical pharmacology Strategy Adviser
- Develop strategy and execute clinical pharmacology plans, PIP Binding elements, and PSP plans
- Prepare you for meetings with regulatory agencies
- Prepare and submit your regulatory applications (2.7.1, 2.7.2, 2.4 sections)