Overview

In an ever changing Regulatory environment, Regulatory authorities around the world mandate drug companies with various Drug labeling formats and standards. To comply with those time-critical labeling mandates, organizations find it challenging to create, track and manage various aspects of drug labeling lifecycle. Major challenges organizations face include:

  • Management of various activities involved in the labeling process like review and approval work-flow
  • Collaboration between global and regional teams
  • Core to regional/national label alignment
  • Change control and deviation management
  • Quick and effective label changes based on new guidelines or drug updates
  • Tracking and compliance

At that time, ineffective tracking could result in high risk of mislabeling and counterfeit drugs leading to product recalls affecting overall finances of the organization. In such adversities, labelers look to implement a centralized label lifecycle management solution for structured and compliant labeling.

Freyr LABEL streamlines end-to-end Regulatory labeling practice in a company of any size. Right from creation, tracking and managing Company Core Data Sheet (CCDS) deviations, CCDS updates, and developments to creating, implementing, and inspecting multi-lingual regional labels as well as custom reporting. Freyr LABEL puts companies in total control of all their regulatory labeling compliance needs to manage the complexity of Regulatory labeling (Core and regional) with a centralized label lifecycle management platform.

 

Freyr LABEL Capabilities

Creation

  • Creation of draft CCDS and corresponding updates
  • Quick and robust CCDS change management

Lifecycle Management

  • Ability to store and archive labeling information and supporting documents
  • Robust review and approval workflow management
  • Audit-trail and record management

Deviation Management

  • Alert based management of label deviations to take action in real-time

Tracking

  • Web-based robust tracking and reporting mechanism
  • Milestone tracking feature
  • Services on developing tools for tracking and maintaining the repository of products
  • Unique inbox enabled forum to track and contribute to discussions and issues

Compliance

  • In-depth and updated understanding of the Regulatory operations in global labeling e.g. submission of the label change to the local Regulatory Authorities
  • Assured data security with minimal setup
  • On-demand simple, cost-effective licensing model
 

Freyr LABEL Features

Creation

  • Easy to navigate UI provides dynamic overview of CCDS for creation of submittable labels

Lifecycle Management

  • Project management capabilities like: status checking, milestone tracking, and data reporting
  • Seamless integration with prominent DMS to store supporting documents for labeling metadata
  • Customizable solution with advanced reporting, audit trail and admin functions
  • Forum enabled labeling tool for contributing and reading discussion on initiatives and issues via inbox

Deviation Management

  • Enhanced email and alert-based notification system to help achieve milestones for on-time project delivery

Tracking

  • Involves proper tracking to ensure the timely implementation of the CCDS information into the local labels as the products are registered in multiple countries/regions

Compliance

  • Centralized labeling content management clubbed with standardized labeling procedures offer entire lifecycle’s visibility for quality compliance 

 

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

Request a Demo
 

Gap Analysis Performed Across a Large Portfolio of 320 Products

Freyr identified missing labels which were collected from markets thus making the global labeling management more efficient.
Download
 

Regulatory Labeling CoE

Leveraging a fully configurable labeling & artwork management software and an efficient global team for tracking global CCDS deviations & updates, Freyr offers companies the best of both worlds – on-demand labeling software solution as well as a Centre of Excellence that offers best in class, cost-effective and custom labelling supporting services model built around clients’ unique and demanding requirements.

Click on below tab to know more about Regulatory Labeling CoE

Read More OR Contact Us

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