About Us

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

ISO 9001 : 2015 Certified for Quality Management Systems
In the area of Good Manufacturing Practices (GMP) and Global Regulatory Affairs

Established in 2012, Metina PharmConsulting is an Indian company headquartered in Mumbai, with subsidiaries in Singapore, Australia & Malaysia. We are a pharmaceutical and bio-pharmaceutical consultancy organization engaged in GMP Consulting, Regulatory services for small molecules & biosimilars, Technical Due-Diligence projects & Portfolio Strategy. Our services span Regulated as well as Emerging 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 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.

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


Experienced professional with over 25 years of work experience in the Pharmaceutical Industry. As a Regulatory Affairs lead in multinationals & currently as an Entrepreneur running a successful consulting service, she has spearheaded regulatory strategy development & implementation for both small molecule generics & biosimilars across emerging & developed countries. She has also established GMP consulting as a core area of strength for the company with over 30 successful EU GMP certifications.
She is the first Indian regulatory professional to be awarded with TOPRA (The Organisation for Professionals in Regulatory Affairs, UK) Fellowship and is closing her PhD in Biosimilars, from the University of Hertfordshire- UK.

The Team

At Metina, the team is young, dynamic and high performing, practising the art of continuous learning! We have 12 in-house technical experts with strong industry experience in regulatory, quality, compliance, project management and portfolio strategy. We do not outsource any work related to our projects.
The directors of the company, Mrs. Hasumati Rahalkar & Dr. Shobhna Aanand, are Pharmaceutical Industry veterans, having held leadership roles across multi-national companies

Corporate Brochure

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