Regulatory Affairs

In the ever-changing global regulatory landscape, our experienced team of industry and former FDA experts ensure you stay on top of the game. Whether you need help in the preparation/submission of ANDAs, an independent final review to evaluate a ready-to-go submission package or checking on application integrity (submitted methods vs methods in practice or an agency requirement due to an inspection or a review outcome), reach out to us and count on us for an excellent winning strategy and support.