Formulation development according to :
- Appropriate regulatory conditions (regulatory status, specific countries, claims)
- Specific requirements (galenic form, quality, price)
- Health benefits and safety
Research, analysis, selection and recommendation of ingredients according to their scientific substantiation and regulatory compliance.
Development of a theoretical formulation, taking into account appropriate efficacy and safety dosage of selected ingredients, potential additional ingredients more likely to be identified and recognized by consumers, other ingredients that may allow the use of Health claims.
- Identification of suitable contract maufacturers depending on the galenic form.
- Completion of a scientific file substantiating the efficacy and interest of the ingredients used for the targeted health application, with bibliographic reference
Validation of the authorization of the selected ingredients in accordance with specifications and selected dosages.
- Support for label compliance
- Notification registration through authorities
EU & USA Regulatory Compliance & Notification
- Compliance analysis & adjustments of composition, rules of labelling, communications
- Label validation
- File development & submission to national authorities (EU only)
- Follow up & exchange through authorization
- Experts & artificial intelligence solutions
- The largest practice in the market (more than 4000 products authorized)
- Regulatory compliance (Formulation, claims..)
- Scientific support compliance (efficacy, interactions, safety...)
- Quality insurance evaluation (process, controls, analysis...)
- Export feasibility in other countries
- Strategic recommendations
- Experts in all these areas of expertise
- Regular practice for investment funds and on most recent deals