Regulatory & safety assessment:

A dossier assembled by the laboratory that generated the data is faster to produce and easier to defend, because nothing is lost in translation between the study report and the file. We prepare cosmetic regulatory documentation under Regulation (EC) No 1223/2009 and support medical device biocompatibility work under the Medical Device Regulation and ISO 10993.

WHAT WE RUN

•  Product Information File (PIF / DIP), part A

•  Cosmetic Product Safety Report (CPSR) for standard and complex formulations

•  Combined PIF and CPSR packages

•  Label and claims compliance review

•  Claims-substantiation dossiers built on our own test data

•  Toxicological pre-evaluation and formula screening

•  Third-country formula compliance checks

•  CPNP notification

•  Regulatory consultancy on a day rate, including EU MDR and ISO 10993 questions

WHAT YOU RECEIVE

A complete, indexed file that a competent authority or an assessor can work through without coming back to you for the missing annex.

WHO THIS IS FOR

Brands placing a product on the European market for the first time, distributors becoming Responsible Person, and device manufacturers facing a biocompatibility gap in their technical documentation.

CALL TO ACTION

Discuss a regulatory & safety assessment project