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, starting from receipt of DCP slot booking, writing Module 1 to Module 5, converting into eCTD, submitting dossier online to RMS and CMSs, responding queries and till product license. Metina has also secured multiple regulatory approvals for products in Asia, Africa, Russia-CIS and Latin America markets.
Metina undertakes EU GMP project starting from pre-audit inspection, EU GMP slot arrangement and obtaining T&C letter from Authority, preparing plant for EU GMP inspection considering Hungary specific expectation of the authority, support throughout inspection, obtaining inspection observation report, submission of CAPA, obtaining EU GMP certificate and ensuring publication of EU GMP certificate in EudraGMP website.
Metina supports pharmaceutical company in developing required dosage forms at accredited formulation development laboratory, in line with EU / US reference product. Post development, the product technology would be transferred to suggested manufacturing location. Metina can also help in identifying contract manufacturing location so as to have product supply.