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Metina PharmConsulting
Your Partner for Global Regulatory, GMP Services & Third-party audits.
About
Metina PharmConsulting Pvt. Ltd. is an India-based pharmaceutical and bio-pharmaceutical consultancy offering global regulatory services, GMP consulting and third-party audits. Its stated service lines are GMP Excellence for pharmaceuticals, biologicals and veterinary products (EU/PIC/S/TGA), drug product regulatory support (EU, UK, Australia, US, Canada, WHO and emerging markets), biosimilars and vaccines regulatory support, API CEP/ASMF/DMF/EDQM GMP services, third-party vendor audits and EU QP audits with technical due-diligence, product development and technology transfer, and product licensing and supply. The company states it was established in 2012 and is ISO 9001:2015 certified for its quality management system.
Deterministic scores · rules-based, not AIiHow these scores are obtained: each one is computed from this profile's listed attributes — capability checkboxes, certifications, capacity figures and coverage — by a fixed formula, recomputed on every page load. Deterministic and rules-based means the score comes from a fixed, transparent formula over listed attributes — the same inputs always produce the same score. It is not AI: there is no model, no learning, and no hidden weighting. Whether a score is relevant to you depends on your specific project: a capability that raises the number may not matter for your work, and a niche strength your project needs may barely move it. Capability scores are a directional starting point, not a verdict. A lower score does not disqualify a company or consultant, and no decision should rest on the score alone — always contact the company directly to confirm the specifics for your project.
GMP expertise iAverages per-area depth across the consultant's listed GMP expertise areas - each area blends proficiency (Foundational 35 up to SME 100, 45%), years of experience (capped at 20, 25%), projects completed (capped at 40, 20%) and inspection support (10%) - then combines 78% depth with 22% breadth (14 points per area, ~7 areas = full breadth). Shows 0 - Developing with no areas listed. Levels: 85+ Elite | 70-84 Advanced | 50-69 Established | below 50 Developing. Whether this dimension matters for you depends on your specific project.
0Developing
Functional depth iAverages each functional specialization group - 60% its SME level (Practitioner 45 up to Authority 100) plus 40% its skill count (20 points per skill, capped) - then combines 75% depth with 25% breadth (17 points per group, ~6 groups = full breadth). Shows 0 - Developing with no groups listed. Levels: 85+ Authority | 70-84 Advanced | 50-69 Established | below 50 Developing. Whether this dimension matters for you depends on your specific project.
0Developing
Regulatory iAdds inspections supported (4 points each, capped at 40), remediations led including Warning-Letter and data-integrity work (5 points each, capped at 30) and regulatory agencies covered (5 points each, capped at 20), plus a 10-point credit for any Warning-Letter remediation. Levels: 80+ Authority | 60-79 Seasoned | 40-59 Experienced | below 40 Emerging. Whether this dimension matters for you depends on your specific project.
20Emerging
Engagement iHow fast and flexibly the consultant can start: availability status (Available now 35, Limited 22, otherwise 10), typical response time (same-day/24h 25, 48h 15, any stated time 8), engagement models offered (6 points each, capped at 25), plus 8 for remote availability and 7 for willingness to travel. Levels: 80+ Immediate | 60-79 Ready | 40-59 Available | below 40 Limited. Whether this dimension matters for you depends on your specific project.
10Limited
Audit readiness iCounts agencies with at least one supported inspection (FDA, EMA, MHRA, PMDA, Health Canada, WHO - 5 points each, capped at 25), total inspections and audits (1.2 points each, capped at 30), mock inspections (3 each, capped at 10), the reported inspection success rate (up to 20; assumed 70% if unreported) and remediations (2.5 each, capped at 15). Levels: 85+ Inspection-ready | 70-84 Strong | 50-69 Established | below 50 Developing. Whether this dimension matters for you depends on your specific project.
14Developing
Industry maturity iClinical-to-commercial lifecycle reach: commercial launches (6 points each, capped at 24), facility startups (3 each, capped at 18), greenfield plus brownfield projects (2.5 each, capped at 14), facilities supported (0.7 each, capped at 14) and manufacturing scales covered (3 each, capped at 12, plus 8 if commercial scale), plus 2 points per industry served, capped at 10. Levels: 85+ Commercial-grade | 70-84 Advanced | 50-69 Established | below 50 Emerging. Whether this dimension matters for you depends on your specific project.
0Emerging
Regulatory agencies
States "ISO 9001 : 2015 Certified for Quality Management Systems". Describes consulting expertise and client work covering EU GMPPIC/S and TGA GMPUS FDA pathways (505(j)505(b)(1)505(b)(2) and 351(k) for biosimilars)EU decentralised proceduresWHO PQPand CEP/ASMF/DMF/EDQM GMP support. These are stated as services delivered for clientsnot authorisations or certificates held by Metina itself.
Primary specializations
GMP consulting (EUPIC/STGA)Drug product regulatory affairs (EUUKAustraliaUSCanadaWHO and emerging markets)Biosimilars and vaccines regulatory supportAPI CEP/ASMF/DMF/EDQM GMP servicesThird-party vendor auditsEU QP auditsTechnical due diligenceProduct development and technology transfer
Coverage regions
Company states an India headquarters with subsidiaries/offices in SingaporeMalaysia (Johor Bahru)Australia (Sydney) and Europe (BudapestHungary)serving regulated and emerging markets including EUUKAustraliaUSCanadaWHO markets and BRICS-TM nations.
Metina PharmConsulting
Your Partner for Global Regulatory, GMP Services & Third-party audits.
Live record · illustrative seed data · scores deterministic, rules-based — not AI.