Metina PharmConsulting Private Limited offer service "USDMF, ASMF (EU-MSs), CEP (EDQM)"

Metina supports the preparation of USDMFs for pharmacopeial and internal-quality active substances, offering development advice, CTD-DMF/eCTD authoring for CDER/FDA submission, deficiency responses, and DMF lifecycle maintenance through major changes. For ASMF, the team writes the Applicant Part and Restricted Part, handles submissions to each EU Member State, and manages query responses; for CEP, it prepares the Applicant and Restricted Parts, submits to EDQM, responds to queries, and supports site inspections through to CEP approval.