Overview

Global Dossier Management implicates tasks that are driven under strict timelines coupled with coordination across local markets in order for companies to expand their prospects in several geographies. The information that is usually distributed throughout huge volumes of country specific source documents seems to be a real-time challenge for companies during compilation. Multiple manufacturing sites further add to impediments in global harmonization which eventually affects the publishing lifecycle.

Freyr has proven experience in dossier preparation utilizing an expert team of regulatory professionals supported by optimized processes, methodologies and a suite of innovative technologies. Our integrated services and solutions have benefited a diverse set of clientele globally.

Freyr provides efficient and robust execution strategies for dossier management with the scope of a minimum number of queries from the regulatory authorities. Freyr experts offer relevant scientific justifications wherever applicable, to avoid further generation of data/RD support thus, enhancing the experience for our clients. 

 

Freyr Capabilities

Pre-submission Consultation for Client

  • Preparation of Project Planner & Guiding client during execution for regulatory requirements
  • Preparation of DMF checklist based on Molecule/type of filing
  • Correspondence with FDA for DMF Number

Gap Analysis to Submission Documents

  • Gap analysis for available docs
  • Preparation of Freyr assessment report & remediation
  • Assisting Client in generation of missing data as per the guidelines
  • Collection of final documents  

Review/Submission

  • Compilation of modules as per CTD requirements
  • Quality Check
  • Final Review by Client
  • eCTD sequence creation
  • ESG submission

Response to Queries

  • Queries & Assessment reports from client
  • Freyr Assessment of reports & gap analysis
  • Coordination with client for generation of data
  • Review for quality checks
  • Response drafting
  • Publishing of next eCTD sequence
  • ESG submission

Post-Approval Management

  • Freyr assessment & gap analysis
  • Finalization of filing strategy
  • Preparation of checklist on type of filing
  • Collection of final documents
  • Preparation & Compilation of amendment
  • Freyr review and quality check
  • Publishing & submission
 

Freyr Advantages

  • First-Time-Right documents
  • Streamlined harmonization for multiple markets
  • Minimalized correction cycles
  • Detailed tracking and assessment of variations & renewals (LCM)
  • Significant cost savings

CLIENT TESTIMONIALS

 
  • We would like to appreciate Freyr for making us equipped with well-defined deliverables to the FDA. For their demonstration of 5-star support, we will use Freyr for our overflow of work. We truly believe in Freyr as a brand and as an expert provider of Regulatory services and look forward to work together on an on-going basis. 

    Terrific Job Freyr, GREAT TEAMWORK!!! 

    - Director of Regulatory Affairs-Operations,
    India based, Global 4+ Bn Pharmaceutical Company

  • During the past several years, I’ve had the pleasure of working with Freyr in the publication, validation and electronic submission of regulatory documentation to the US FDA. The Freyr team has provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.

    President,
    An Independent regulatory and quality consulting company

  • Freyr was a great find indeed. The Freyr Publishing team catered excellent Study Report publishing services. The icing on the cake was their proper coordination, flexibility, dedicated study team, timely and constant communication and subject matter expertise that added to the ease of doing business and towards successfully accomplishing the end goal. This, as well as the fair pricing, is what sets Freyr apart from their competitors. As always, I would recommend Freyr again with no hesitation and should the opportunity arise, we absolutely approach Freyr.

    Project Manager,
    A full-service Clinical Research Organization (CRO)
    Based in Florida

  • We are making great progress and we are impressed with Freyr’s commitment to success and willingness to be flexible; you clearly have capable and experienced people in your organization.

    – VP and Head of Regulatory Operations of a Global Top 5 Pharma & Consumer Company

  • We would like to congratulate Freyr team for their excellent service and error free XEVPRM submission with short notice and well within the regulatory timeframe. We sincerely appreciate their technical skills and their extraordinary and selfless effort.

    We are pleased to acknowledge the timely support and recommend Freyr to everyone who are looking for such services.

    – Vice President, Clinical Research & Pharmacovigilance, Microlabs

  • It has been an absolute pleasure working with Freyr over the past few months. Thank you very much for all the hard work – I could not imagine how difficult it would have been without the team being so proactive and diligent.

    I look forward to returning to work with you in January and an exciting new chapter in our time.

    – GRA Operations Program Manager, Top 5 Global Pharmaceutical Company

  • We have made great progress in a short duration and are impressed with the 162 positive acknowledgements from EMA for the XEVMPD submission project.

    I would like to thank the entire team for their support for critical XEVMPD compliance activities.

    Program Manager, Global Top 5 Pharma and Consumer Health Company

  • I would like to thank the Freyr team for all the support they have provided. The Ops team is very satisfied with the level and quality of services from all the resources that we have on board.

    Thanks to their commitment and discipline, we were able to deliver on all key objectives that had been outlined for us in 2014.

    - Head of Regulatory Operations, Top 5 Global Pharmaceutical Company

  • As we near the completion of a major filing, I would like to thank Freyr and recognize the team resource’s performance. It has been a great addition to our team and throughout all the projects, the involvement has been impeccable, illustrating not only professional demeanor, but in-depth skills, dedication, attention to details, willingness to switch gears and deliver timely results.

    We recognize and acknowledge the exemplary performance and look forward to working together.

    – Manager, Regulatory Operations, Global Top 20, $20+ Bn,
    Pharmaceutical Company

  • Great company for eCTD and regulatory supporting is Freyr. I am approaching the end of our first year engagement and we are extremely satisfied with the quality of their resources and leadership. They also have their own suite of tools for publishing eCTD and from what I have seen they offer a very viable publishing solution.

    - Associate Director, Regulatory Technology and Ops,
    Global Top 20 Pharmaceutical Company