Labeling

Frevor offers end-to-end labeling services and support for global and regional labeling management, professional assistance in drafting Investigational Brochure (IB), Developmental Core Data Sheet, and Developmental Core Safety Information.

From initial labeling assessment to determine your needs and to help you understand labeling regulations, we handle complex tasks, such as creating, updating and maintaining the Company Core Data Sheets (CCDS).

Clinical Labelling

Every product in investigational study needs labels and they have to different from any other medicinal product as being patient specific. Variety of labeling-related tools are utilized to facilitate drug development along with labeling objectives.

We employ a customized approach while collecting the evolving safety and efficacy information across various types of clinical labels to focus the need of investigators and sponsors more effectively.

Global Labeling

Due to constantly evolving Regulatory requirements, organizations must ensure that the product information related to manufacturing, safety and efficacy, mentioned on the labels is controlled by maintaining a central or core reference product information.

The primary information of a Core label is derived from the Investigator Brochure (IB) and is continuously revised. Company Core Data Sheet (CCDS) may also be used as an attachment to a Periodic Safety Up-date Report (PSUR).

Fervor extensive experience in the field of labeling, and Core labeling in particular, makes it an ideal resource for companies that create or revise CCDS and CCSI and harmonize local safety labeling. Our experienced labeling team not only tracks the country-specific labeling standards for on-time implementation of the labeling changes, but also provides cost-effective global labeling management consultation.

Product labeling is designed to serve multiple functions across several regions and countries. On a basic level, national and regional health professional (HP) and patient and consumer labeling communicates information pertaining to the benefits and risks of the product. It also offers advice on the effective and safe use of the same product. Biopharmaceutical companies take advantage of the national/regional HP labeling to find out whether they could expect a suspected adverse drug reaction for purposes of expedited reporting to local Regulatory authorities. The exact labeling content of national and regional labeling is generally negotiated between biopharmaceutical companies and Regulatory authorities. At the same time, it would benefit organizations if they were to achieve core to local label harmonization, saving on time while aligning with region-specific requirements of labeling. Label safety alignment must also be ensured with the reference label.

Regional Labeling

Medical Device Labeling

Medical device manufacturers face an array of challenges in delivering their products to domestic and international markets. With potential risks to patient safety, Regulatory review, and ultimately brand equity, organizations must ensure that labeling documentation complies with the current product standards prevalent in each country distributing their devices.

This varied definition multiplies the challenges usually faced while attempting to meet international Regulatory compliance. While identification and other international safety standards assist in tracking products through the global supply chain, a variety of such standards in use today only complicate harmonization efforts further. For manufacturers, the supply chain can include contract manufacturers, private label and re-label partners, distribution points, and point- of- use healthcare providers. With a comprehensive knowledge of global medical devices market clubbed with proven expertise in Regulatory services, We offers end-to-end labeling services that span across updating, reviewing, analyzing, tracking and maintaining label changes.

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