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. It is also necessary for these organizations to adopt practices that enable them to react quickly in order to process change requirements.
For medical device manufacturers, the definition of labeling includes any type of packaging or product identification, as well as anything that describes the product, its capabilities, and its intended use. 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, Freyr offers end-to-end labeling services that span across updating, reviewing, analysing, tracking and maintaining label changes.
- Create, update & review contraindications, warnings, precautions
- Create, update & review Instructions for Use (IFU)
- Quality check of submission and commercial artworks
- Gap analysis between distributed labels & submitted labels
- Tracking and maintaining label changes
- 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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