Metina PharmConsulting
Pharmaceutical and biopharmaceutical consultancy (est. 2012) headquartered in Mumbai with subsidiaries in Singapore, Malaysia, Australia and Europe. Provides regulatory affairs, GMP compliance, due diligence, dossier authoring and product development support for regulated and emerging markets, with specific expertise in biosimilars, vaccines and EU/PIC/S/TGA GMP pathways.
Industries
Nr. of Employees
small (1-50)
Metina PharmConsulting
Mumbai, Maharashtra, India, Asia
Services
Gap assessment, mock audits, QMS documentation, inspection management and CAPA support for pharmaceuticals and biologics.
Scientific writing, compilation and submission of CTD/ACTD dossiers, regulatory strategy, query response and lifecycle management for APIs and finished products.
End-to-end regulatory and technical support for biosimilar and vaccine product development including CMC authoring, analytical comparability and clinical/non-clinical regulatory packages.
DMF/ASMF/CEP preparation and submission, EDQM/CEP certification assistance and API supplier QP audit support.
Vendor qualification audits, technical due diligence, QP audits and risk assessment for manufacturing and supply chain partners.
Formulation development, technology transfer package preparation and transfer support aligned to reference products and regulatory expectations.
Gap assessment, mock audits, QMS documentation, inspection management and CAPA support for pharmaceuticals and biologics.
Scientific writing, compilation and submission of CTD/ACTD dossiers, regulatory strategy, query response and lifecycle management for APIs and finished products.
End-to-end regulatory and technical support for biosimilar and vaccine product development including CMC authoring, analytical comparability and clinical/non-clinical regulatory packages.
DMF/ASMF/CEP preparation and submission, EDQM/CEP certification assistance and API supplier QP audit support.
Vendor qualification audits, technical due diligence, QP audits and risk assessment for manufacturing and supply chain partners.
Formulation development, technology transfer package preparation and transfer support aligned to reference products and regulatory expectations.
Expertise Areas
- GMP compliance and inspection readiness
- Regulatory dossier authoring and submissions (CTD/ACTD)
- Biosimilars and vaccine development regulatory strategy
- CMC and analytical comparability for biologics
Key Technologies
- Mammalian and microbial recombinant expression systems
- Upstream and downstream bioprocessing
- Working/master cell bank strategies
- Analytical comparability and functional bioassays
News & Updates
Published materials including a review on challenges faced by the biopharmaceutical industry and guidance documents on biosimilar monoclonal antibody development.
Poster summarizing comparative evaluation of mAb biosimilar development and licensing regulations in BRICS-TM markets.
Published article available via Springer on regulatory and development challenges for biopharmaceuticals.
Published materials including a review on challenges faced by the biopharmaceutical industry and guidance documents on biosimilar monoclonal antibody development.
Poster summarizing comparative evaluation of mAb biosimilar development and licensing regulations in BRICS-TM markets.
Published article available via Springer on regulatory and development challenges for biopharmaceuticals.