A trusted team in regulatory affairs

In order to navigate a safe passage through the vast sea of regulatory requirements, you need a map, a compass, and most of all an experienced team behind you. SDS Life Science can be that team for you.

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.

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