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Scientific and Regulatory Affairs
Our customers have trusted Gyma to help them navigate the labyrinth of pharmaceutical regulations, for decades. Our experts provide comprehensive guidance through each step of the process from R&D to analytical development to pre- and post-approval regulatory submissions.
Regulatory teams at Gyma help file and maintain Drug Master Files (DMF) and Certificates of Suitability (COS) in virtually any regulated market across the world. Our team is well acquainted with the Generic Drug User Fee Amendment (GDUFA) and ensures that all required Gyma-represented API suppliers have self-identified with the US Food and Drug Administration (FDA).
What sets us apart?
We don’t just stop at regulatory affairs; our team of experts can help with any and all troubleshooting from a simple OOS to complex formulation issues. Our work doesn’t just end with liaising our customers with the right partners but continues to managing the entire drug life-cycle from concept to commercialization. We strive to be first-in last-out, putting our partners and customers in the best position for success. We literally go all in!
Abbreviated New Drug Application (ANDA) and 505(b)(2)
When it comes to generic drugs, speed matters. Starting from 1971, Gyma has enabled pharmaceuticals to launch over a thousand first-to-market APIs under ANDA filings.
For our partners looking to create new combinations from known APIs, make current drugs more effective or introduce new administration routes for older drugs, Gyma can simplify and expedite the 505(b)(2) application process. This helps deliver access to the best pharmaceutical care worldwide. Under the 505(b)(2) application, Gyma has enabled over 40 novel drugs to come to the markets across the world.