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.
While a lot of countries and regions offer a two-tiered labeling system with patient and consumer information as well as HP labeling, Canada offers a three-tiered system with some detailed scientific information beyond what is included in the “regular” HP labeling.
- Development of Prescription and Patient Labels for all regions and countries
- Lead cross-functional and therapeutic area groups for label development and review
- Develop/review Medication Guides and Instructions for Use
- Provide labeling insight and strategy to arrive at consensus
- Labeling review and compliance
- Health Authority (HA) interactions and negotiations
- Support Regulatory agencies requiring labeling information
- Reference label change monitoring for Generics and Biosimilars
- Preparation of label comparisons for HA submission
- Legacy product support for all countries
- Proofreading and departmental Quality Control (QC)
- Labeling operations (packaging, bottle labeling and artwork systems)
- Core to local label harmonization
- Local label safety alignment with reference label
- Resources with in-depth Regulatory knowledge
- Expertise in successfully handling global and regional drug labeling for Fortune Pharma clients across the globe; USA, EUROPE, APAC, MENA etc.
- Global Regulatory expertise in covering life sciences organizations viz. Pharma, Biotech, and Nutrition manufacturers
- Highly qualified medical writers possessing extensive Regulatory labeling experience
- In-depth and updated understanding of the global drug labeling changes from multiple Health Authorities such as: USFDA, EMA, TGA etc.
- Dedicated compliance team tracking the status of core and company core data sheet (CDS / CCDS) implementation in regional labels
- Highly experienced Pharmaceutical, Biotech and Nutrition labeling professionals
To streamline end-to-end Regulatory labeling practice from creation to tracking to managing in company of any size, Freyr offers a centralized labeling life cycle management software, Freyr LABEL. Right from creating, 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.
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