Regulatory Services for small molecules

Metina provides end to end regulatory services starting from due diligence, gap analysis of the dossier, product development guidance, regulatory strategy, scientific writing of dossier, submission to health authority, query response and approval. Our services covers API and Formulation for USA, EU, WHO PQP and Emerging Markets as well. During last few decades, we have managed to obtain multiple submission and approvals for ANDAs, DCPs, National Submissions in EU, WHO PQP, MCC-South Africa and TPD-Canada. Metina has already filed 505(j), 505(b)(1) and 505(b)(2) application with USFDA and received approvals. Apart from that, Metina has performed multiple controlled correspondence with USFDA. With regard to EU, Metina has filed DCP application multiple regulatory approvals for products in Asia, Africa, Russia-CIS and Latin America markets.