Regulatory Labeling services

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.

Regulatory 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.