Freyr DMF Capabilities Overview

Overview

Freyr supports global firms to maintain the lifecycle of the DMFs, update/amend existing DMFs with the USFDA, convert existing DMFs to eCTD, handles dossier compilation for DMFs in eCTD format and serves as your agent for the USFDA communications.

Freyr Advantages

  • Flexible eCTD publishing software for end-to-end Regulatory publishing and submission services
  • Provision of expert advice on region-specific DMF submission requirements and various other Regulatory submission formats
  • Acts as a single point of contact for each submission

New DMF Filing

  • Preparation, review and submission of DMF with Health Authorities
  • DMFs are filed to ensure minimal or no queries during the review process
  • End-to-end Regulatory consultation
  • Gap analysis of generated documents against current Regulatory requirements
  • Agent services for the US and Canada

CEP (Renewals/Variations)

  • Preparation, review and submission of CEPs
  • Preparation, review and submission of CEP renewals
  • Preparation, review and submission of sister CEPs
  • CEPs are filed to ensure minimal or no queries during the review process
  • End-to-end Regulatory consultation
  • Gap analysis of generated documents against current Regulatory requirements

DMF Conversion to Electronic Format

  • Update of DMFs as per with current GDUFA requirements
  • Gap Analysis of existing DMF
  • Authoring of modules as per CTD Format
  • Publishing of updated DMF in eCTD format

DMF Amendments/Variations

  • Evaluation of change request and appropriate filing strategy
  • Preparation, review and submission of annual reports, biannual updates, amendments and variations to DMFs with scientific justification and supporting data for quick approval
  • Change notifications are shared with ANDA/ANDS/MAA holders for respective DMF/ASMF/CEP
  • Expertise in filings amendments/variations with respect to:
    • Manufacturing site transfer
    • Change in ROS
    • Optimization of the manufacturing process
    • Alternate source for starting material
    • Changes in the specification and test methods
    • Extension of retest period

Tools Experience

  • Existing DMF for the adequacy of the already filed content against the current Regulatory requirements in CTD format
  • Source data/documents against current GDUFA requirements for Type II US DMFs
  • Source data/documents against current requirements for DMF submission to other Agencies like Health Canada, EDQM, TGA, EU and other global countries
  • Source data/documents generated for amendments/variations against the requirements in line with variations/guidance on post-approval changes

Latest Resources

  • Blogs

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    ANVISA Becomes a Member of PIC/s Committee

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  • White Papers

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    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

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  • Webinars

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner?

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What Our Clients Say?

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