Metina PharmConsulting Private Limited

About Metina PharmConsulting Private Limited

Metina is a  pharmaceutical consulting firm having expertise in submissions and approvals for USA, EU and Emerging Markets and expertise in filing & approval of ANDA, NDA, NCE as well as Branded Generic Products across the globe. Metina currently offers consultancy services to Pharmaceutical Industry and covers end to end regulatory and business development activity covering strategy development, due diligence of dossier, in-license/out-license of dossiers, Submission Management to Health Authorities, product market launch. It also offers consultancy services for EU GMP approvals, API QP Audits to the manufacturing sites in India and Worldwide.

  • IN
  • 2015
    On CPHI since
Company types
Contract Service
Contact info
  • 901-903, Goodwill Infinity, Sector 12, 410210, Mumbai, India
Meet us at

CPHI Frankfurt 2022

Messe Frankfurt, Germany
1-3 November 2022

CPHI & PMEC India 2022

India Expo Centre, Greater Noida, Delhi NCR
29 November - 1 December

Products from Metina PharmConsulting Private Limited (5)

  • API EU QP Audit

    Product API EU QP Audit

    Metina provides support to API manufactures one time audit by independent auditor for single API. It provides benefits to the manufactures to conserve company's resources (i.e. cost of travel and stay for buyer specific auditor, one-time engagement of manufacturing and QA personnel), one single QP audit ca...
  • Drug Product Development, CDMA identification and Technology transfer of product

    Product Drug Product Development, CDMA identification and Technology transfer of product

    Metina supports pharmaceutical company in developing required dosage forms at accredited formulation development laboratory, in line with EU / US reference product. Post development, the product technology would be transferred to suggested manufacturing location.  Metina can al...
  • Regulatory Services for small molecules

    Product Regulatory Services for small molecules

    Metina provides end to end regulatory services starting from due diligence, gap analysis of the dossier, product development guidance, regulatory strategy, scientific writing of dossier, submission to health authority, query response and approval. Our services covers API and Formula...
  • EU GMP

    Product EU GMP

    Metina undertakes EU GMP project starting from pre-audit inspection, EU GMP slot arrangement and obtaining T&C letter from Authority, preparing plant for EU GMP inspection considering Hungary specific expectation of the authority, support throughout inspection, obtaining inspection observation repo...
  • ANDA Submissions and Approvals

    Product ANDA Submissions and Approvals

    Metina has efficiently managed multiple ANDA's submissions and approvals. Metina provides assistance starting from regulatory advice during product development, controlled correspondence with FDA, writing of scientific dossier in CTD, conversion into eCTD, online submission support to USFDA, query response...

Metina PharmConsulting Private Limited Resources (1)