Our services in regulatory affairs:
- We implement regulatory strategies from the early phase to market launch.
- Guide you through early and late phases towards a MAA or NDA.
- Prepare and execute meetings with the authorities such as EMA, FDA, CDE in China, and the PMDA in Japan.
- Sets the strategy for Conditional Approval, Orphan Drug Designation, PRIME, Exceptional Circumstances, Break-Through Designation or Fast-Track.
- Other components of the regulatory strategy like Target Candidate Drug Profile, Target Product Profile, strategy to support label claims, evaluation of alternative indications and the fastest way to market.