Regulatory Affairs Consultancy
Pharegistrum supports companies with regulatory strategy, documentation and product procedures before the relevant authorities. Based in Lisbon and operating since 2007, we provide pharmaceutical and technical consultancy tailored to the product and stage of the project.
From regulatory strategy to product registration
Our support can begin before an application is submitted and continue through registration maintenance. We prepare documentation and liaise with regulatory authorities on behalf of clients.
- Regulatory strategy and preparation of marketing authorisation dossiers, including eCTD.
- Product registration with bodies such as INFARMED, DGAV, DGS, ECHA, CPNP and CIAV, depending on the product.
- Registration maintenance: variations, renewals and updates.
- Preparation and review of labelling, package leaflets and advertising materials.
Support for different product categories
Our services cover medicines, medical devices, food supplements, cosmetics, veterinary products, biocides and detergents. The scope of each project is defined according to the product.
- Medical devices: support with CE marking and technical dossiers.
- Cosmetics: preparation of product information files (PIFs).
- Veterinary products: authorisation and registration applications.
- Preparation of safety data sheets and applications for CNP codes.
Starting your regulatory project
Tell us about the product, intended markets, available documentation and current project stage. This helps us define the scope of support and prepare a proposal suited to your needs.
