Regulatory Affairs
Regulatory environments of expertise:
| Region | Agency | Standard |
| Global | ISO | ISO 22716 |
| Europe | EU | Eu Reg. 1223/2009 |
| Portugal | Infarmed | Eu Reg. 1223/2009 |
| USA | FDA | FD&C Act, Title 21CFR |
| Canada | Health Canada | Food and Drugs Act, C.R.C., c. 869, C.R.C., c. 870 |
| Brazil | ANVISA | RDC 48, RDC 15, RDC 7 |
Product's notice (EU): preparation of the product information file and submission on the CPNP.
Safety report (EU): writing of the report of safety evaluation.
Regulatory surveillance: file update according the evolution of regulations and the product life cycle.
Labelling revision: supervision of labelling information.
Marketing claims revision: supervision of marketing claims and advertising materials.
Product Compliance: product documentation review for compliance analysis in different regulatory frameworks.
EU imports: we can be your Cosmetic Responsible Person for the EU.
Good Manufacturing Practices Implementation: we audit your facilities, provide you the checklist and policy to adopt. Preparation for authorities inspection - GMP, GLP, ISO 22716.
Quality Assurance: we prepare your quality assurance manual, general procedures, SOP.
