Dossier building

A well-structured product dossier (PIF) including country specific details and requirements 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

Together with you we will jointly create a fully compliant PIF to start with. 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 and regulatory compliance assessments, label and claim review, and the mandatory toxicological hazard risk assessment report.  The PIF needs continuous updating when for example raw materials, suppliers and/or labels change.