Overview

Data and documents to be submitted to several Health Authorities are constantly changing and increasing in frequency, volume and, complexity. New regulations and guidelines demand Life Sciences companies to constantly look at ways of providing the required information to Health Authorities in order to be compliant.

In many cases, existing software and systems might not be able to keep pace with the ongoing Information requested or required by Health authorities. It typically takes more time for a software (3rd party or internally built) system to be able to provide the required information.

Freyr has a dedicated team providing cost-effective, Regulatory Data Management solutions (A creative combination of agile software tools and regulatory resources) that can be an interim or even a long-term approach for solving time-sensitive Regulatory Information Management & Regulatory Reporting needs

 

Freyr Capabilities

  • Data Cleansing / Data entry in 3rd party Regulatory & Compliance software and other Custom- software of Bio-Pharma companies
  • Design & Development of quick, agile & validated, software tools and accelerators that interface with multiple systems to provide required information
  • Regulatory Data Management services, with well-defined SOPs and audit-trail
  • Custom Report design and development for Compliance needs
  • Building software-based integration kits between R & D / Regulatory / Quality / Safety and other systems – Enabling systems to Interact with each other and handle data-flow between systems
  • Regulatory Data Quality checks
  • Adding Metadata to Regulatory Documents and Regulatory DMS
 

Freyr Advantages

  • Meeting short IT CSV -Validation timelines, especially for the information required is from GxP systems
  • Scheduled Software Vendor product  release aligned with Pharma company’s submission deadlines
  • Managing data that is not supported by existing systems and is available in silos (Mail boxes, local disks, other intranet locations)
  • Setting-up strategies to reduce artwork changes globally
  • Provide reports and information where data does not interact properly with different systems and needs to be combined from multiple systems
 

High Quality Assured For 98% of Data, Successfully Audited By FDA

Freyr established Process Automation for client handling large volumes of data and reducing dependency on humans for Quality Assurance.
Download
 
Freyr rDMS

Freyr rDMS

Freyr rDMS is an end-to-end electronic Regulatory Document Management solution 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.

Click on below tab to know more about Freyr’s Regulatory Document Submission and Tracking Solutions

Read More

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