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 life cycle. 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 life cycle management platform.

 

Freyr LABEL Expertise

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, for example, 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 user interface (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 Document Management Systems (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 life cycle’s visibility for quality compliance 

 

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

Get a Quote / Request a Demo
 

Freyr Service

Freyr offers End-to-end labeling services and software support for global and regional labeling management, CCDS creation and updation, core to local label alignment etc.

Our team of highly qualified medical experts track status of the data sheets implementation in local labels, review and suggest the changes to the data sheets and write the clinical overviews for submission to the Health Authorities.

Click on below tab to know more about Regulatory Labeling CoE

Read More OR Contact Us