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 APIs and Formulations for USA, EU, WHO PQP and Emerging Markets as well. We have obtained multiple submissions and approvals for ANDAs, DCPs, National Submissions in EU, WHO PQP, MCC-South Africa and TPD-Canada. Metina has filed 505(j), 505(b)(1) and 505(b)(2) application with USFDA and received approvals while performing multiple controlled correspondence with USFDA. In EU, Metina has handled DCP applications starting from receipt of DCP slot booking, writing Module 1 to Module 5, converting into eCTD, submitting dossier online to RMS and CMSs, responding to queries till product approval. Metina has also secured multiple regulatory approvals for products in Asia, Africa, Russia-CIS, Latin America, Australia and UK.
In the last few years, Metina has built expertise in the area of Biosimilars and Vaccines and we are now equipped to take on end-to-end regulatory support for this category of products across BRICS-TM (including India) countries and regulated markets. We have a strong connect with regulatory agencies including ANVISA, MoH Russia, CDSCO, SAHPRA, COFEPRIS, TITCK, TGA, SwissMedic, TPD Canada, for biosimilars products.
In the domain of Quality and Compliance, the company has established a strong track record of success with EU GMP & PIC/S services. Metina undertakes EU GMP projects starting from pre-audit for gap assessment, EU GMP slot arrangement, obtaining T&C letter from Authority, preparing plant for EU GMP inspection considering specific expectations 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. We are also fully equipped to carry out inspections from regulatory bodies including PIC(S), WHO PQP, TGA, TPD and others.
With our strong expertise on regulatory and compliance, we are well equipped to handle all kind of Technical Due-diligence Projects and provide unbiased opinions to Financial Institutions and companies for investment projects in the pharmaceutical industry.
We also support pharmaceutical companies in Developing Pharmaceutical Products across dosage forms at an accredited formulation development laboratory, in line with EU / US reference product. Post development, the product technology can be transferred to the suggested manufacturing location.
International Association
Metina has a strong connect for regulatory and commercial tasks across EU, USA, Asia, Africa (Including MENA), GCC, Latin America and Russia / CIS region.
Hasumati Rahalkar