Overview

Smarter the eCTD publishing software, smoother will be the eCTD submissions process. The Life Sciences and Medical Device companies are looking for a robust and effective submission publishing software to gain fast-track approval from regulatory agencies for marketing new drugs, biologics and devices. The documentation Lifecycle covers a complete clinical and preclinical research data accumulated over the years. And the submission requirements vary depending on the specific regulations of each country; USA, European Union, Canada, GCC, Saudi Arabia, Oman, South Africa, Switzerland, Australia, New Zealand, Bosnia & Herzegovina, and Thailand. As companies move towards fulfilling their submission obligations, either DMF or SPL or baseline submissions, under strict compliance timelines, they face increasing complexities to efficiently manage multiple documents and different formats across the entire submission process.

Some of the major challenges faced by the companies include:

  • Need for a robust regulatory publishing software to streamline and effectively manage the entire Lifecycle, and to root out all errors during the submissions compilation and validation
  • Ineffective submission solutions due to partial integration with commonly available DMS
  • Unending performance issues due to complex architecture & unnecessary features of eCTD software
  • Unfriendly and rigid eCTD submission software structure with limited customizable product features
 

Freyr Capabilities

End-to-end DMF, SPL and baseline submissions workflow with detailed checks during compilation, validation, and publishing functions
Robust audit trail & reporting mechanism
Advanced admin functions with capabilities to monitor lowest level user activity & highly customizable access management
Effective validation of each and every user activity via electronic signatures
Flexible eCTD publishing software for end-to-end regulatory submission publishing services
 

Freyr Features

  • A lightweight and faster application built on a robust architecture with a simple, user-friendly interface
  • A ready-to-use, flexible and cost-effective eCTD software offered either as a cloud hosted or on premise deployable model
  • Easily processes US, EU and GCC, Australia Thailand eCTD submissions with automated system-defined eCTD formats / templates
  • Our eCTD software supports emerging markets’ submission requirements
  • Enables automated template library updates (for all formats / templates) with systematic and customized notifications
  • Advanced features to efficiently manage the entire eCTD Lifecycle
  • Completely customizable eCTD software with advanced reporting, audit trail and admin features
  • Seamless integration with prominent DMS

 

 

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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Regulatory Submission and Publishing CoE

As an effective and robust submission-friendly eCTD software on a secure cloud environment backed by a well-versed regulatory team keeping track of ever changing regulatory guidelines, Freyr offers companies the best of both worlds – on-demand eCTD software as well as a Centre of Excellence that offers best in class, cost-effective and custom eCTD outsourcing service models built around clients’ unique and demanding eCTD software requirements.

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CLIENT TESTIMONIALS

 
  • During the past several years, I’ve had the pleasure of working with Freyr Solutions 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 outsourcing is Freyr Solutions. 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