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

What Our Clients Say?

It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.

President

An Innovative Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.

Quality Control and Regulatory Manager

USA-based Pharmaceutical company

The ANDA receipt is 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 look forward to working with your team on the next project!

Research and Technology based US pharmaceutical company

Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.

Senior Research Assistant,

US based leading biopharmaceutical company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.

Operations Head,

A Privately Held Pharmaceutical Research and Development Company

Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.

System Owner,

UK multinational pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.

Graphics Manager | Global Regulatory Affairs,

Canada based, global pharmaceutical company

Freyr DMF Capabilities Overview

Overview

Freyr Advantages

New DMF Filing

CEP (Renewals/Variations)

DMF Conversion to Electronic Format

DMF Amendments/Variations

Tools Experience

Insights

Blogs

White Papers

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