Business And New Product Development

Industrial Projects

Licenses And Supplies

Regulatory Affairs Department

Hospital Projects

Technology Transfer

Vegal Farmacéutica offers a professional support as specialized and complete as possible which is adapted to the new regulatory demands and requirements of the different Health Authorities to obtain marketing and market placement authorizations for MEDICINAL PRODUCTS, MEDICAL DEVICES, COSMETICS, FOOD SUPPLEMENTS, MEDICINAL PRODUCTS FOR VETERINARY USE, PLANT EXTRACTS, BIOCIDES, DENTIFRICES...

The main services that we offer include:

- Compilation of documentation for submitting regulatory affairs dossiers by National and European procedure (MRP, DCP and Centralized Procedure).

- Adaptation of dossiers to NEES and e-CTD format.

- Type I / type II variations.

- Revalidations.

- Expert reports.

- Leaflet legibility tests.

- Adaptation of texts (technical data, leaflet and labeling) to QRD.

- Literature searches.

- Technical translations.

- Evaluation and validation of regulatory affairs dossiers to confirm the compliance of regulations in force.