Metina is a Pharmaceutical and Biopharmaceutical Consultancy Organization engaged in GMP Consulting, Product development, Regulatory services and Portfolio identification for small and large molecules across the globe. The company has achieved multiple ANDA and DCP approvals, as well as PIC/s & EU GMP certifications for varied dosage form. Metina provides end to end regulatory services starting from due diligence, gap analysis of dossier, product development guidance, regulatory strategy, scientific writing of dossier, in-license/ out-license of dossier, submission to health authority, query response and approval. In the area of EU GMP, Metina has successfully conducted over 30 inspections nationally and internationally with 100% success rate as on date.
Why Metina
Reliable regulatory and quality partner to the Bio-/pharmaceutical industry by providing comprehensive inputs and time bound services.
Adept at WHO PQP and biosimilar intelligence advice for BRICS-TM market.
International presence with subsidiaries in Malaysia, Singapore, Australia and Europe.
Strong Agency & commercial connect for Regulatory and Marketing tasks across EU, USA, Asia, and Africa, GCC, Latin America, Russia / CIS region.
Complementary skills in Portfolio Strategy & Business Development across India, EU, Emerging Markets.
Industry
Pharmaceutical Manufacturing
HQ Location
901-903 Goodwill Infinity, Sector 12
Kharghar
Navi Mumbai, Maharashtra 410210, IN
Keywords
Regulatory ServicesProduct DevelopmentRegulatory Tools & Medical WritingDue Diligence of Technical DossierDrug Master File (DMF)CTD / National DossiersSubmission to Health AuthorityRegulatory Inspectionsand Financial Institutions Consulting