Global Labeling Services

As a critical aspect of product lifecycle management, global labeling is one of the complex processes of the life sciences’ Regulatory environment. Due to constantly evolving Regulatory labeling requirements, organizations must ensure that the product information related to manufacturing, safety, and efficacy mentioned on the core labels is controlled by maintaining central or core reference product information.

A core labeling document (CDS-Core Data Sheet) is an internal Regulatory labeling document that serves as the company’s global reference document for a product. Core labeling is used to communicate the company’s position to the appropriate stakeholders worldwide for the inclusion of safety and efficacy information on country-specific labels. Core labeling is prepared before or after the Regulatory approval (or another Regulatory pathway) to market a medicinal product worldwide.

The primary information of a core label is derived from the Investigator Brochure (IB) of a clinical trial, and it is continually revised by adding more information from post-marketing sources like post-marketing safety and efficacy studies and post-marketing surveillance data.

The Company Core Data Sheet (CCDS) may also be an attachment to a Periodic Safety Update Report (PSUR). All the safety information mentioned in a CCDS ("Company Core Safety Information" or "CCSI") or a specifically identified (e.g., by bold print) subset of this safety information, serves as reference information for determining "listedness."

The CIOMS III/V and VI guidelines describe some general criteria regarding the inclusion of safety information in a CCDS/CCSI. However, labeling regulations, guidelines, and expectations have significantly changed and become more specific since the CIOMS III and III/V reports were published. Considering these developments is crucial from a Regulatory and legal/litigation standpoint. Equally important for the Regulatory viability and defensibility of CCDS and CCSI content and global labeling harmonization are carefully drafted and effective rationales and supporting documentation (Clinical Overviews).

Freyr’s unique experience in labeling, and specifically core labeling, makes it an ideal resource for companies that create or revise CCDS and Company Core Safety Information (CCSI) and harmonize local safety labeling. Freyr has expertise in the preparation of label justification documents and global deviation management to prepare clients for deviations in the results. Freyr’s experienced labeling team tracks the country-specific labeling standards for on-time implementation of the labeling changes and provides cost-effective global labeling management consultation.