Metina PharmConsulting Private Limited offer service "Regulatory Services for small molecules"

Metina delivers end-to-end regulatory services—due diligence, dossier gap analysis, product development guidance, regulatory strategy, scientific dossier writing, health authority submission, query response, and approval—for APIs and formulations across the US, EU, WHO PQP, and emerging markets. Over recent decades it has secured submissions and approvals for ANDAs, DCPs, EU national procedures, WHO PQP, South Africa's MCC, and Canada's TPD, filed and gained USFDA approval for 505(j), 505(b)(1), and 505(b)(2) applications, engaged in multiple USFDA controlled correspondences, and obtained regulatory approvals via EU DCP filings for products across Asia, Africa, Russia-CIS, and Latin America.