ClinChoice has a global multi-disciplinary team with vast experience in providing strategic inputs and managing operations to maintain compliance with health authority regulations worldwide. Our services are girded by technical and scientific expertise that uses our insights from regulatory intelligence to meet our clients’ needs in every market.
Food Supplements
Product Registration & Lifecycle Management
- Authoring and submission of product registration and notification dossiers
- Preparation and submission of novel food applications
- Management of queries from local food authorities
- Preparation of submission package for variation and renewal applications
- Provide technical strategy for variation management
- Update of client regulatory information databases
- Preparation of Product Data Sheets (PDS)
Composition Analysis
- Review of composition (acceptability, specific requirements, deviation allowed) with vitamins, minerals, and botanical ingredients
- Calculation of Recommended Dietary Allowance (RDA) per country-specific requirements with respect to specific age groups
- Evaluation of permissible limits for additives
- Recommendations of alternative ingredients or additives
Regulatory Intelligence
- Collation of scientific and regulatory data for market expansion
- Provide scientific evidence for food product categorization
- Assessment of ingredients and additives for sustained compliance
- Preparation of regulatory strategy to get marketing authorization for ingredients and additives
Labeling Management
- Creation of labels based on country-specific regulations
- Review of product marketing documents based on country-specific labeling requirements and advertisement regulations
- Generation of a nutrition fact table based on the composition of the product
- Development of product information leaflet, container closure statement, and packaging specifications