Regulatory Affairs

We assist foreign and local companies in obtaining the proper registration status of their products in Portugal.

Our team has a consolidated experience in the Regulatory area, either in registration of medicinal products, medical devices, food supplements and cosmetics.

In parallel, we assure the fulfilment of Pharmacovigilance obligations such as periodic searches and safety updates’ elaboration, adverse reactions notification management and sales team periodical training in Pharmacovigilance. We offer a complete range of activities: · piloting and conducting the full registration process of medicinal products at local Authorities - via MRP, DCP and national procedures · submission and monitoring of the post-registration variation process maintenance of Marketing Authorisation (renewal process) preparation, translation and adjustment of the texts of Patient Information Leaflets (PIL), Summary of Product Characteristics (SmPC), outer and immediate packaging (mock-ups) to the requirements of the local Authorities Medical Devices translation and preparation of packaging materials (mock-ups) for notification to the local Authorities notification of food supplements to the appropriate local Agencies, including translation and development of packaging materials (mock-ups) and technical information required for such notification preparation, translation and adjustment of cosmetics in order to apply for registration at local Authorities Our extensive experience allows us to give advice as to the most effective submission procedures that result in successful approvals. We assure full confidentiality and customer data protection.