Address: Vía de las Dos Castillas, 9, 28224 Pozuelo de Alarcón, Madrid. Spain.
Telephone: + 34 917 99 09 10.
The regulatory affairs service was created as a part of Grupo Vegal and since then this department has carried out many projects in Spain and abroad.
We are all aware of the importance that this service has for the pharmaceutical sector and its implications with the different departments: quality control, quality assurance, regulatory, R & D, legislation… In this way, multinational laboratories also demand services as a complement to their own ones, being in some situations insufficient.
1. We advise in the definition of the Strategic Development Plan (Regulatory Development Plan) according to the specific Regulatory requirements of the client.
2. Support to select the best regulatory strategic procedure, preparing development plans (clinical, non-clinical and quality) in agreement with the Regulatory agencies through meetings with the regulatory agencies and the preparation and submission of scientific advice.-
3. Advice on the responses to the letter of incidence from the regulatory agencies.
4. Great experience in the different European registration procedures:
- Decentralised procedure (DCP).
- Mutual recognition (MRP).
5. Advice in registration procedure and documentation required in the following countries: LATAM, MENA and ASIA.
6. Preparation of all the documentation needed for the registration dossier and technical package for the sanitary products and medical devices.
7. The post-authorization maintenance of a product constitutes a great part of the routine activity of the Regulatory departments (variations, renewals and notifications). Our regulatory team has many years of experience and is responsible for the maintenance activities of different companies.
8. Audits: our team has the knowledge and experience necessary to carry out audits of dossiers of medicines, sanitary products, medical device, biocides, cosmetics and alimentary supplements.