About Us

To support pharmaceutical and bio-pharmaceutical companies to build, grow and expand their international presence

Metina is a pharmaceutical and bio-pharmaceutical consultancy organization engaged in GMP and Regulatory services for small and large molecules across the globe. The company has achieved multiple ANDA and DCP approvals, as well as EU GMP certifications for varied dosage forms. The company offers WHO PQP, emerging market regulatory expertise and biosimilar intelligence advice for BRICS-TM markets.

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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.

International Associates

Metina has strong connect for regulatory and marketing task across EU, USA, Asia, Africa (Including MENA), GCC, Latin America and Russia / CIS region which results in quick MA approvals and Site GMP for our clients.

Our Vision

To be a reliable regulatory and quality partner to the pharmaceutical and bio-pharmaceutical industry by providing comprehensive, knowledge driven & time bound services, with impeccable work ethics.

Founder's Profile

Hasumati Rahalkar

RAC (US, EU), MTOPRA

Hasumati Rahalkar is the founder and Director of Metina PharmConsulting. She brings more than 25 years of Regulatory and GMP experience in Pharmaceutical and Bio-pharmaceutical industry. As Director of the company, she manages and overview all the projects, build the team and impart technical knowledge within the team and industry. Her approach is client satisfaction, knowledge upgradation, integrity, honesty and confidentiality of data. Her strive for knowledge is visible in ongoing research in biosimilar area through Hertfordshire University, UK.

Corporate Brochure

You can learn more about us by downloading our Corporate eBrochure.