Overview

Freyr rDMS is an end-to-end electronic Regulatory Document Management system exclusively designed to enable Regulatory Groups and Departments within a life sciences organization to seamlessly create, capture, manage, organize, connect, deliver and archive regulatory data and documents in a compliant, efficient and intuitive manner.

While traditional Document Management Software Solutions are typically retrofit for regulatory needs, Freyr Regulatory Document Management Software is built ground-up, keeping specific nuances and expectations of regulatory strategies and operation functions in mind. Our solution combines an end-to-end set of features spanning the whole document lifecycle from inception and authoring up to submission and archiving of regulatory documents.

With capabilities to efficiently handle enterprise-wide content and ease of integration with legacy systems, Freyr rDMS provides an integrated platform to address the critical need for knowledge sharing across the enterprise.

 

Freyr rDMS Capabilities

  • End-to-end set of features spanning the whole document lifecycle from inception and authoring up to submission and archiving of regulatory documents.
  • Seamless organization of document monitoring process to ensure compliance with worldwide regulatory authorities.
  • Robust and secure tools to manage an extensive range of regulatory documents associated with business extents controlled by the FDA and other international regulatory systems.
  • Advanced Admin functions to manage users and monitor activity.
  • Easy management of document mode, status, and version.
 

Freyr rDMS Features

  • Focuses primarily on storage and archiving and document lifecycle management
  • Includes powerful work flow for incorporating business processes into the management of the documents
  • Targets at storing and presenting documents in their native format (not limited to MS-Office products but including many different information formats)
  • Document access is restricted at the folder or document level with advanced security rules applied
  • Provides document statistics based on – Checked-in, Checked-out, Review, Publish, and Approve modes
  • Integrates advanced feature to create groups and assign related documents to groups
  • Advanced Folder creation, management, view, and search functionality
  • Comprehensive dashboard providing folder and document overview
  • One Stop Doc Center to view and manage user access based overview with secure user roles
  • Doc Groups to easily manage various documents
  • Advanced search functionality based on Doc Groups and document meta tags
  • Bulk action capability on clinical trial documents

 

To Know More about Freyr rDMS and to take a feature-specific comprehensive product tour.

Request a Demo
 

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CLIENT TESTIMONIALS

 
  • 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 outsourcing 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