DMF Capabilities

 

DMF Capabilities - 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.

DMF Capabilities - Expertise

  • 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
  1. Preparation, review and submission of DMF with Health Authorities
  2. DMFs are filed to ensure minimal or no queries during the review process
  3. End-to-end Regulatory consultation
  4. Gap analysis of generated documents against current Regulatory requirements
  5. Agent services for the US and Canada
CEP (Renewals/Variations)
  1. Preparation, review and submission of CEPs
  2. Preparation, review and submission of CEP renewals
  3. Preparation, review and submission of sister CEPs
  4. CEPs are filed to ensure minimal or no queries during the review process
  5. End-to-end Regulatory consultation
  6. Gap analysis of generated documents against current Regulatory requirements
DMF Conversion to Electronic Format
  1. Update of DMFs as per with current GDUFA requirements
  2. Gap Analysis of existing DMF
  3. Authoring of modules as per CTD Format
  4. Publishing of updated DMF in eCTD format
DMF Amendments/Variations
  1. Evaluation of change request and appropriate filing strategy
  2. Preparation, review and submission of annual reports, biannual updates, amendments and variations to DMFs with scientific justification and supporting data for quick approval
  3. Change notifications are shared with ANDA/ANDS/MAA holders for respective DMF/ASMF/CEP
  4. 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
  1. Existing DMF for the adequacy of the already filed content against the current Regulatory requirements in CTD format
  2. Source data/documents against current GDUFA requirements for Type II US DMFs
  3. Source data/documents against current requirements for DMF submission to other Agencies like Health Canada, EDQM, TGA, EU and other global countries
  4. Source data/documents generated for amendments/variations against the requirements in line with variations/guidance on post-approval changes
DMF Capabilites

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​