Welcome To Metina PharmConsulting

ISO 9001 : 2015 Certified for Quality Management Systems
In the area of Good Manufacturing Practices (GMP) and Global Regulatory Affairs
Established in 2012, Metina is an India based company with its headquarters in Mumbai and subsidiaries in Singapore, Malaysia and Australia.

Metina is a pharmaceutical and bio-pharmaceutical consultancy organization engaged in GMP consulting, Regulatory services for small molecules & biosimilars, Third Party QP Audits, Technical Due-Diligence projects & Portfolio Strategy. Our services span Regulated as well as Emerging Markets. Our technical team comprises of skilled resources with core bio/ pharmaceutical industry experience having in-depth and updated understanding of GMP, Regulatory Affairs, Portfolio Strategy, Product Development and Project Management.

We strive to be a reliable Regulatory, GMP, Due-Diligence partner to the industry by offering comprehensive, knowledge driven, time bound and high quality services.


Compliant to the highest ethical standards, our teams act with integrity and honesty and treat all client data with highest confidentiality. We do not outsource any services.


Our young and dynamic team of technical experts are passionate workers and accountable for results.


We provide high quality, time bound services with high degree of success


Quality and compliance are at the core of every action of a Metina team member

Constant Improvement

We strive to improve our service constantly through learnings and feedback

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.

Our Main Services

GMP Excellence : EU/ PICS/ TGA/ Health Canada

GMP pre-audits, Compliance advise and bridging support, QMS documentation, Facility upgradation advise, mock up inspection, QP audit, EU GMP inspection to certification hand holding, annual report submission.

Drug Product Regulatory – EU, UK, Australia, US, Canada, WHO & Emerging Markets

End to End Regulatory Services covering Regulatory Strategy, Scientific Dossier Writing, Submission to Health Authority, Exigencies response, Pricing approval, Marketing Authorization Approval & Product Life Cycle Management.

Biosimilars & Vaccines Regulatory Support

BLA review, Scientific writing and CBER submission under 351(k) pathways with USFDA, Centralised application under Article 10(4) with EEA, Expert intelligence for biosimilar licensing in BRICS-TM markets.

EDQM Preparation & API CEP/ DMF Services

DMF/ASMF/CEP scientific writing, Submission with Agency, support in resolving questions, Third Party API QP audit, QP audit Report, CAPA preparation, QP Declaration, CEP Certification, EDQM GMP support.

Third Party QP Audits, Vendor Qualifications & Due-Diligence

Third Party QP Audits, Vendor Qualifications & Due-DiligenceThird Party QP Audits, Vendor Qualifications & Due-Diligence

Portfolio Partnerships

Portfolio Projects across the value chain, ranging from market specific portfolio strategy, defining regulatory pathway,  product development, commercial launch & local partnership

Our Growth

In less than decade, Metina has grown exponentially in varied technical services starting from regulatory science to quality certifications for the manufacturing sites. Metina has advanced further by developing internal expertise for Biosimilar products development and trained pharmaceutical professionals in technical area.
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What Our Clients Say

Products Category

The Drug Products Category we operate with:


505 (b)(2) and 505(j) application with USFDA, Article 10 (1) submission in EU and national submission with independent agency.

Veterinary Medicines

EU GMP for veterinary medicines and product dossier filing with MAH in EU.

New Drugs

Super generics development support and approval.


EU & Emerging markets submission and approval support.


BLA submission via 351(k) pathway, Article 10(4) application with EU, BRICS-TM regulatory intelligence and submission.


EU and Emerging markets regulatory intelligence and submission support.

Our Esteemed Clients