Welcome To Metina PharmConsulting

Established in 2012, Metina is India based company with headquarter in Mumbai and affiliated company in Singapore.

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.

Ethical Standards

Compliance to highest ethical standards

Knowledge

Highly knowledgeable and experienced internal experts

Dependable

Time bound project execution

Success

100% success for EU GMP and regulatory services.

Compliance

ANDA filing with full compliance with RTR standards.

Integrated

Integrated services for regulatory filing in EU via DCP / Centralised / National procedure.

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

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.

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.

EU GMP Excellence

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.

PIC/S GMP Proficiency

Product trigger 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.

Biosimilar Intelligence

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.

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.

GxP Calibre

Clinical or BE center GCP preparation and PIC/s or EU inspection arrangement, Toxicology or Analytical Laboratory support for OECD accreditation, Annual audit and gap analysis report.

Global Dossier Development

Technical guidance to develop global dossier, Conversion of non-CTD to CTD and eCTD dossier, National dossier writing, Country specific guidance and check lists, Gap evaluation of in-licensed dossier.

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.
Awesome Image

What Our Clients Say

Products Category

The Drug Products Category we operate with:

Generics

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.

Herbal

EU & Emerging markets submission and approval support.

Biosimilars

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

Cosmetics

EU and Emerging markets regulatory intelligence and submission support.

Our Esteemed Clients