A leading consumer company based in America planned to launch their new range of Nutraceutical, Dietary Supplements and OTC products in 3 different countries (India, Singapore, and Vietnam), which have completely different Regulatory frameworks. Some of the key business challenges client faced en route include:
- Understanding varied Regulatory frameworks across various complex markets
- Staying abreast with the complex and evolving Regulatory guidelines and regulations
- Developing effective market-specific Regulatory strategy for quick and successful market entry
With expertise and experience in delivering Regulatory support to food and food supplements industry, Freyr understood the Regulatory operational challenges confronted by the client and developed strategies for their products’ quick market launch.
Regulatory Solutions Offered:
Product Assessment and Regulatory Strategy for New Products:
An end-to-end formula assessment was carried out to analyse the acceptability of ingredients, additives, vitamins, minerals, enzymes, amino acids in different countries. Region-specific product classification assistance provided, identified prohibited and new dietary ingredients (NDI), and provided recommendation on the reformulation of the product.
Re-classification of Product to Health Supplement as per applicable regulations and guidelines for SINGAPORE (OTC to Health Supplement Switch strategy)
Region-specific gap analysis and evaluation of the label and formula/brand claims statement to ensure compliance with existing regulations
Claims were defined and supported with scientific literatures wherever required
Local language translation support was provided for country specific labels
Formula Review/ Ingredients Assessment
Checking status of all ingredients in the client’s product formula and advise on the acceptability criteria of levels, RDAs, limitations of use or prohibitions, if any
Regulatory Documentation Support/ Lifecycle Management
Analyzed and evaluated all the documents related to the Regulatory, Safety, and Quality, Shelf life and Stability parameters and provided Regulatory consulting for changes in the documents as required
Represented client in various meetings with global stakeholders, external agencies like FDA, FSSAI, Trade Associations, and Advertising council
With on time Regulatory consulting, Freyr successfully launched 15 products of the client in all the 3 markets within the desired timeframe and we are awarded with the project extension for launching clients’ 50+ products across the globe.