In order to navigate safe passage through the vast sea of regulatory requirements, you need a map, a compass and most of all an experienced team behind you. We can be that team for you.
Our services in regulatory affairs:
- We implement regulatory strategies from 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.
How can we help you?