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

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

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.  For ASMF, writing Applicant part (AP) and Restricted Part (RP), submission to each MSs, Query response and ASMF acceptance.
For CEP, writing applicant Part (AP) and restricted part (RP), EDQM submission, Query response, Support for EDQM site inspection and CEP approval Letter.

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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

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