Overview

All packaging components (artwork copy, design elements) must comply with the regional/local market regulations and should carry all safety-related information as per the guidelines. The same shall be shared with the Artwork studio for artwork creation and should be validated by Regulatory Affairs professionals for packaging artwork design production. Without an expert review, the label or artwork or packaging might be non-compliant.

Freyr has the expertise to support Regulatory affairs labeling and packaging artwork lifecycle. The team is equipped to create manuscripts for the product in accordance with the Regulatory guidelines. Freyr has a strong Regulatory Affairs team to handle end-to-end labeling activities and is proven for serving many brands in the regulated industry.

Freyr Expertise

  • Authoring Prescriber labels (PI, SPC, USPI), patient labels (PIL, Medication Guide), & Instruction for use (IFU) required for creation of packaging artworks
  • Authoring local language text documents for artwork creation
  • Regulatory Intelligence-driven working model for label updates
  • Review documentation related to Regulatory labeling and artwork
  • Initiate immediate label changes if any, due to safety requirements
  • Artwork lifecycle management from initiating artwork change request to review to approval of local artworks

Freyr Advantages

  • Right-first-time approach
  • Proficiency in making technical checks related to packaging artwork design
  • Freyr Regulatory Affairs team ensure that labeling artwork meets all requirements
  • Accuracy of commercial packaging components
  • Constant communication with lifecycle managers
  • Timely delivery of all new and revised text on Regulatory Affairs labeling artwork components

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.

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