Seratec registers DMFs of innovative or generic APIs to the US-FDA or EMEA on behalf of pharmaceutical laboratories, mainly US based. Seratec can handle highly potent APIs in accordance with cGMP (regularly inspected by the US-FDA) from the gr to the ton, from complex, even multi-steps, organic synthesis, essentially within the context of niche markets.
Successfully, Seratec was appointed as the main orphans manufacturer for the biggest hospital organization in Europe.Hence, Seratec promotes the talent of its multidisciplinary team, which settles our business by managing efficiently the time required for an approval of our customers' drug applications.
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