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, 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

Drug Product Regulatory – India & Other 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.

Medical Devices in India

Medical devices in India are categorized into A, B, C and D classes based upon the associated risk and Indian regulatory bodies have defined procedures for license applications. This includes rules for the import of medical devices.

EU GMP ( Pharmaceuticals/ Biologicals)

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.

Master File Submission (API)

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.

PIC/S GMP Proficiency

Product triggered GMP inspection from Malaysia, Regulatory Submission, MA Holding, ACTD dossier writing, Deficiencies closure, hand holding for GMP improvisation, Product approval & Site GMP accreditation, Market support.

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.

Due-Diligence for Mergers & Acquisitions

With our core expertise in the area of quality, compliance and regulatory affairs, we provide technical consulting to financial institutions/ pharmaceutical companies to facilitate decision making for investment/ divestment projects.

Regulatory Training

Customised training for multiple technical topics based on current norms, GMP specialized training sessions, Regulatory training for product development, dossier writing, CTD management and Life Cycle Management.

Product Life Cycle Management

Renewal, re-registration, Annual report, Variation submissions & approvals, line extension management, Registration maintenance, PV compliance, technology transfer documents evaluation & approval.

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