Dossier building

A well structured product dossier (PIF) is indispensable, central to many regulatory processes, and a legal requirement. It includes key information on raw materials, suppliers, production methods, products, producers, brand owners, and the consumer history of use of the products.

The basis for compliance and safety

As the start we will jointly create a comprehensive PIF fully compliant with the (EU) Cosmetics Regulation (EC) 1223/2009. We will provide clear instructions and checklists for your R&D, manufacturing, QC and procurement departments to ensure that all required data, documents and test reports are timely and correctly included in the PIF.

The PIF holds input to many mandatory activities such as the safety assessment, label and label ingredients review, and the mandatory cosmetic product safety report (CPSR). And the PIF needs continuous updating when for example raw materials, suppliers and/or labels change. Cosmetovigilance records need to be continuously updated to include the latest information on the consumer history of use and potential (serious) undesirable effects.

Fully digital

Our co-developed software for product regulatory information management will provide great efficiency and quality benefits. It has specifically been designed to build and maintain full up-to-date PIFs, and to have 24/7 safety and compliance evaluation of raw materials, formulations, products and product labels against regulatory and toxicological data.

The use of the software proved key in passing recent EU authority inspections with our clients.