Our Regulatory Consultancy team is experienced in cannabinoid chemistry (including CBD and other plant derived cannabinoids), manufacturing, regulatory and related analytical methodology.
They support our members in generating the required scientific dossiers for novel foods applications and guide them in other issues they may face.
ACI Regulatory Consultancy services include
- Introduction to novel foods dossier requirements
- Customer checklist reviewed and signed off by ACI
- Gap analysis based on checklist results
- Definition of project timeline and approval
- Full review of each section on completion
- Advice on identifying partners for stability testing and advice on identifying partners for product testing
- Formulation-specific risk assessment guidance
- Guidance on:
- Stability data protocols
- Specification controls
- Supply chain visibility HACCP, GACP and other critical control points
- Guidance on data generation, such as toxicological data or ADME studies
- Overall risk assessment & risk mitigation plan guidance
