OUR SERVICES

Regulatory Affairs activities in Portugal, other European countries and third countries.

- Marketing authorization of medicinal products application submission and follow-up;

- Decentralized and Mutual Recognition Procedures submission;

- Preparation and submission of marketing authorization variations;

- Preparation and submission of marketing authorization renewals;

- Article 126 submissions;

- eCTD submissions;

- Due Diligence to dossiers;

- Dossier consolidation (Module 1 to Module 5);

- Strategic guidance on Regulatory scenarios;

- Technical Translations;

- Preparation, submission and follow-up of registration of cosmetic products, food supplements and biocides;

- Preparation, submission and follow-up, including market vigilance of medical devices;

- Marketing and promotional material review of medicinal products and health products;

- eCTD submissions;

- Support to technical training;

- Local contact with Authority.