RA food
New food and food ingredients, dietary supple-ments, functional foods (like nutraceuticals). natural health products, and food derived from biotechnology processes all present business opportunities and challenges. Our experts can help navigate the scientific and regulatory requirements these products must meet to be marketed. Xendo delivers the complete range of services needed for the successful preparation, submission, and support of food and food-related dossiers in the EU and abroad.
Strategy
- Regulatory intelligence
- Submission strategy
- Data requirements
- Interaction with Regulatory Authorities
- RA project management
Documentation
- Dossier preparation (e.g. novel foods, dietary supplements, direct and indirect food or feed additives, processing aids, food and
feed enzymes)
- Preparation of safety dossiers for regulatory and legal purposes
- Writing scientific papers to support product approval processes
- Labelling
Scientific Services
- Conducting food safety evaluations, e.g. toxicology, allergenicity, exposure assessments (e.g. contaminants)
- Designing, outsourcing and monitoring safety, nutritional and efficacy studies
- Identification and substantiation of health-related claims for foods as well as food components and supplements
- Conducting critical literature reviews
- Second opinion
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