Regulatory Artwork Labeling: Overview
All packaging and Regulatory artwork labeling 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 packaging and artwork labeling components shall be shared with the Artwork studio for artwork creation and should be validated by Regulatory artwork labeling 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 artwork labeling services. At Freyr, the team is equipped to create manuscripts for the product in accordance with the Regulatory guidelines and provides best-in-class artwork labeling sevices. A strong regulatory artwork labeling services partner to handle end-to-end labeling activities is a proven advantage for many brands in the regulated industry.
Regulatory Artwork Labeling – Freyr Expertise
- Authoring prescriber labels (PI, SPC, USPI), patient labels (PIL, Medication Guide), & Instruction for Use (IFU) required for the 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 requests to review to the approval of local artworks.
Regulatory Artwork Labeling – Freyr Advantages
- Right-first-time approach
- Proficiency in making technical checks related to packaging artwork design
- Freyr’s Artwork Regulatory Affairs labeling team ensures that artwork labeling meets all requirements
- Accuracy of commercial packaging components
- Constant communication with lifecycle managers
- Timely delivery of all new and revised text on Artwork Regulatory Affairs Labeling 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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