Regional Labeling Services - Overview
Freyr's Regional Labeling Services are designed to serve multiple functions across several regions and countries.
A label communicates information to Health Professionals (HP), patients, and consumers about the benefits and risks of the product. It also offers advice on the effective and safe use of the same product.
Biopharmaceutical companies rely on national/regional HP labeling to determine whether they could expect a suspected adverse drug reaction for expedited reporting to the local Regulatory authorities. The exact labeling content of the product labeling is negotiated between biopharmaceutical companies and Regulatory authorities. At the same time, it would benefit organizations to achieve core-to-local label harmonization, saving time while aligning with region-specific labeling requirements. Label safety alignment must also be ensured with the reference label.
While a lot of countries and regions offer a two (02)-tiered labeling system with patient and consumer information as well as HP labeling, Canada offers a three (03)-tiered system with some detailed scientific information beyond what is included in the “regular” HP labeling.
Freyr’s Regional Labeling Services
Regional Labeling
- Development of prescription and patient labels for all regions and countries
- Management of cross-functional and therapeutic area groups for label development and review
- Develop/Review ‘Medication Guides’ and ‘Instructions for Use’
- Provide regional labeling compliance insights and strategy
- Global and regional labeling review and compliance
- Health Authority (HA) interactions and negotiations
- Support Regulatory agencies requiring global and Regional Labeling Services
- Reference label change monitoring for generics and biosimilars
- Preparation of label comparisons for HA submissions
- Legacy product support for all countries
- Proofreading and departmental Quality Control (QC)
- Quality and compliance check of local or regional labels
- Labeling operations (packaging, bottle labeling, and artwork systems)
- Technical/Structured Product Labeling
- Core to local/regional label harmonization
- Local label safety alignment with a reference label
- Global drug safety labeling changes
- Resources with in-depth Regulatory knowledge
- Expertise in successfully handling global and regional drug labeling for Fortune pharma clients across the globe, such as the USA, EUROPE, APAC, MENA, etc.
- Global Regulatory expertise in helping life sciences organizations, viz. pharma, biotech, and nutrition manufacturers
- Highly qualified medical writers with extensive Regulatory labeling experience
- In-depth and updated understanding of the global drug labeling changes from multiple HAs such as the USFDA, EMA, TGA, etc.
- A dedicated compliance team to track the status of core and company core data sheet (CDS/CCDS) implementation in local or regional labels
