Assessment
Regulatory classification and feasibility
Before registering, you need to know what the product is in the eyes of the rules and whether the path is viable. We assess classification, restrictions and regulatory strategy — from cosmetics to software as a medical device (SaMD) — and deliver a report that guides the decision.
What we deliver
- Regulatory classification and risk class check
- Assessment of substances, concentration limits and indication restrictions
- Registration feasibility analysis and category strategy
- Classification and compliance report with adjustment suggestions
Who it's for
Companies and startups with a new product (cosmetic, device, health software) that need to decide the path before investing.
Documents we usually request
- Product description, composition or formulation
- Intended use and claims
- Available technical documentation
Not included
- Registration submission
- Contact with laboratories
- Translation beyond English and Spanish