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Services in Regulatory Affairs

Promising new drug substances are often substances of biological origin. The development of biotechnological medicinal products is fascinating and Sirega has specialized in these products:

We have extensive experience in writing quality dossiers both for IMPDs/INDs and Marketing Authorization Applications.

Drug substances groups we have been working with are mRNA, mAbs, cytocines (INFs, epoetins), hGH, vaccines, allergenes and advanced therapies medicinal products (ATMPs)