Overview

In an ever evolving dynamic regulatory environment, new directives and regulations are increasingly posing real-time challenges for companies to effectively navigate the complex submissions’ landscape inclusive of eCTD baseline submissions, and DMF in eCTD format / NeeS format. Added to that, efficiently managing multiple eCTD formats, documents and dossiers throughout the Lifecycle can severely stress a company’s resources, budgets, and the overall process of electronic submissions to FDA and Health Authorities (HAs), within short timelines.

Freyr provides flexible, end-to-end eCTD publishing services to enable companies effectively meet all their specific and unique submission requirements for the approval of drugs, biologics and medical devices. Right from dossier development, planning, tracking, publishing and submitting final documents to HAs to delivery confirmation/acknowledgement, Freyr streamlines the entire Health Authority (HA) submission management process to ensure error-free, timely and quality regulatory submissions throughout the Lifecycle.

Freyr team has an extensive experience in handling various submission types, for US FDA and other HAs, such as:

 

Freyr Capabilities

Region-wise Dossier Development Plan / Submission Planning and Life Cycle Management/ Geo-Specific

  • Multi-country compliant regulatory submissions for: USA, EU, Canada, GCC, Saudi Arabia, SA, Switzerland, Australia, New Zealand, Bosnia & Herzegovina, and Thailand
  • Document mapping across regional submissions
  • Sequential relationship building for submissions, and variations
  • Converting Non-eCTD electronic format (NeeS format) or paper format to eCTD format and vice versa
  • Using appropriate eCTD versions inclusive of accurate eCTD Modules, eCTD Formats, and eCTD Structure
  • Expertise in paper to eCTD transformation
  • Drug Master Files (DMF) conversions, submissions
  • Dedicated compliance group for specialized US agent service

Submissions Document Development and Publishing

  • Managing and processing source documents
  • Insertion of navigation aids
  • Managing source documents in a secure and web based regulatory document management system
  • Publishing of Case Report Forms (annotated and hyperlinked)
  • Creating submission-ready documents
  • Document level & report level formatting as per respective HA guidelines
  • Consultative support

Submissions Compilation / Dossier Compilation

  • Module creation
  • Cross-functional document tracking
  • Metadata compilation/template management
  • Dossier Lifecycle management
  • History management
  • Leaf documents compilation
  • Study Tagging Files (STF) creation, and management
  • Validation using appropriate Industry-accepted / Agency-recommended tools

Quality Review and Delivery / Publishing

  • Step-wise validation of the packages
  • Backbone XML Validation
  • Checksum Verification
  • Thorough QA/QC of modules and dossiers
  • Metadata verification with respect to country specific regulatory requirements: USA, EU, Canada, GCC, Saudi Arabia, SA, Switzerland, Australia, New Zealand, Bosnia & Herzegovina, and Thailand
  • Burn CD/DVD master
 

Freyr Advantages

  • Robust eCTD Structure built on acknowledged standards that haven’t changed much all these years while integrating ICH requirements
  • Upgraded tools to review electronic regulatory submissions to offer sturdy performance
  • Common eCTD format for both US & Europe with relatively simple changes (eCTD Module 1 and STF acceptance)
  • Detailed history along with easy knowledge transfer for product
  • Consolidated formation offers transparency to regulatory submissions
  • Simple tools integrated for eCTD publishing services
  • Similar methodology that of paper work
  • Share updates with multiple local affiliates involved in the process of electronic submissions to FDA and other Health Authorities
  • No viewer requirement during the submission process
  • Affordable implementation
 

Accelerating Ahead Of Competition Delivering Faster Time to Approval 

Freyr helps a global client with fast-track ANDA submission within 3 weeks, increasing in cost benefits by 70%.
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Freyr SUBMIT

Freyr SUBMIT

Freyr SUBMIT is a complete eCTD software product for the creation, validation, publishing, viewing and reporting of regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities.

Learn more about Freyr’s eCTD Submission Solution

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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