Sinerga provides a constant support to its customers in terms of Regulatory Affairs, concerning Cosmetics, Medical Device and Raw materials.
Our Regulatory Dept. provide a broad range of services:
COSMETICS
- Verification of formulation compliance with the requirements of CEE regulation n. 1223/2009.
- Constant monitor on the legislative adjournments in order to inform the client accordingly.
- Support in the selection of safety and efficacy tests to carry out the product’s launch.
- Evaluation of the correct wording, claims and icons to be printed on labels and packaging.
- Drafting of P.I.F. (Product Information File) and related safety assessments.
- Support and notification at the European portal CPNP (Cosmetic Products Notification Portal).
- Support in the creation of documents useful to export in non-EU countries.
MEDICAL DEVICE
- Verification of formulation compliance with the requirements of the Directive 93/42/CEE; legislative decree February, 24th 1997, n. 46.
- Support in the choice and implementation of biocompatibility tests in collaboration with the most qualified testing laboratories.
- Support in the choice of a protocol for clinical investigations and the subsequent implementation.
- Support in the preparation of the technical dossier.
- CE Marking.
COSMETIC RAW MATERIALS
- Safety Data Sheets in accordance with the 1907/2006 Regulation (EC) and subsequent amendments.
- Drafting of technical datasheets.
- Creation of Technical Dossiers.
- Verification of compliance with major international inventories (IECIC, DSL / NDSL AICS ICL etc.).
- Compilation of COSMOS, ECOCERT, NATRUE questionnaires.
- Additional documentation available (questionnaires, additional efficacy tests...) to fulfill the customer’s requirements.
