Nutraceuticals & Nutricosmetics

Our cross-technical team composed of scientists, engineers, pharmacists and regulatory/legal experts has remarkable experience in the development and registration of both food and drug products. We use our expertise in the development of innovative drugs and biologics to maximally creatively address the increasing regulatory challenges in the nutraceutical sector.

Our teams have synergistic backgrounds and perspectives to coordinate knowledge and expertise in order to work efficiently with companies pursuing a strategy of convergence and developing innovative nutraceutical or borderline products.

Strategic regulatory support incorporating life cycle management for foods and food products with health claims, including:
- Functional Foods, Food/Dietary Supplements
- Foods for Particular Nutritional purpose (PARNUTS), Medical Foods, FOSHU
- Novel Foods, Genetically Modified substances
- Botanical and Traditional Herbal Products
- Probiotics and Prebiotics
- Nutricosmetics

Guidance on optimal regulatory pathway and notification/registration procedure in global markets
Development of notification/registration dossiers in key global markets including EU, US, Asia
Due diligence, gap analysis and identification of regulatory market readiness plans
Determination of compositional and labeling requirements
Review of product claims and pertinent supporting data
Support with design of clinical trials to meet regulator’s expectations
Development of health claim application dossiers (EFSA, FDA)
Representation with regulatory authorities
International product registration support
Advice on cosmeceutical products
Vigilance reporting service