API EU QP Audit

API EU QP Audit
Product Description

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 can replace numerous MA holder audits. Single Comprehensive CAPA execution to independent EU QP auditor as against multiple CAPAs to different EU QP auditors. 

Read more Show less

Metina PharmConsulting Private Limited

  • IN
  • 2015
    On CPHI since
Company types
Contract Service
View company profile
Categories
more categories Show less

Metina PharmConsulting Private Limited

  • IN
  • 2015
    On CPHI since
Company types
Contract Service
View company profile

More Products from Metina PharmConsulting Private Limited (4)

  • 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)