Regulatory Support
for health and beauty products
(Food supplements / borderline products / drugs / cosmetics / essential oils)
Regulatory strategy
- Choosing the regulatory status best suited to the product's future positioning
- Consideration of the constraints and opportunities of each status
- International knowledge and understanding of different regulatory status
Compliance with various legislations
- Regulatory validation of formulas and safety analyses
- Development in compliance with current regulations (e.g. mandatory testing)
- Product label validation
- Validation of claims
- Validation of all communication tools and media
Approvals of food supplements and cosmetics
- Writting all required information for cosmetics and food supplements. Product Information Files (PIF) and food supplement files (especially for export)
- Interaction with the authorities, assisting with notifications of food supplements and cosmetics
- Registration with appropriate authorities
Marketing authorizations of drugs
- Assistance with European marketing procedures such as preparation of Agency meetings (e.g. briefing documents)
- Assistance with the Preparation and Review of the different modules of the CTD (Common Technical Document)
Product Marketing
- Assistance in setting up sanitary vigilance (e.g. crisis committee) for food supplements and cosmetics
- Monitoring regulatory changes for all types of regulatory status
File Auditing
- Scientific and regulatory audit of technical and communication files for various regulatory status (cosmetics, food supplements, drugs)
