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REGULATORY SERVICES


Regulatory Services

We have the expertise to provide expert clinical and regulatory support through all phases of global drug development to commercialization, from BA/BE Analysis to Quality cGMP compliance. We prepare all regulatory documentation including filing of DMFs, ANDAs and maintaining post approval change management. Our proficiency in organizing quality dossiers ensures timely approvals. We have the bandwidth to support clinic and regulatory activities across USA, EU, Asia Pacific and Latin America.