Regulatory Training

Regulatory Training
Product Description

Metina has expertise in providing training on the regulatory guidance as both In-house and onsite training. The training topics are designed considering R&D, QA, QC, Production and Regulatory Affairs. Regulatory training can be diversified with more than 100 regulatory and quality topics. So far, many of the successful training programs has been conducted on the topics of WHO PQP, EU GMP, Regulatory submission in EU, etc.

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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 (8)

  • 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...
  • GxP Inspection Service

    Product GxP Inspection Service

    Metina provide comprehensive support for the ARD and F&D Site GMP verification, API and FDF manufacturing Site GMP verification, BE and clinical site GCP verification and GLP verification audits. We extend the support to the storage facilities also.  
  • USDMF, ASMF (EU-MSs), CEP (EDQM)

    Product USDMF, ASMF (EU-MSs), CEP (EDQM)

    Metina provides support to write USDMF for Pharmacopoeia and internal quality active substance, DMF, development advice, writing of CTD-DMF & eCTD submission to CDER, FDA, Deficiency response for complete assessment review of DMF, maintaining active status of DMF support in major change updates.  ...
  • Product Lifecycle Management

    Product Product Lifecycle Management

    Commitment to conditional approval, PV Compliance, Annual Report, CBE and PAS to USFDA, Type I &II variation for EU, Maintenance of Registration, Renewal & Re-registration and Line Extension. 

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