Regulatory Affairs

Pharmaceutical department that aims to ensure public health protection by ensuring the efficacy and safety of medicinal products, medical devices, cosmetics, biocides, and food supplements.

We provide a complete regulatory service with the highest quality standards and practical expertise, from the introduction of a drug on the market to MA terms variations, so that the life cycle is always covered and the medicinal pr marketed in accordance with the laws and regulations in force.

 

Marketing Authorisations

• National Procedure
• Mutual Recognition Procedure
• Decentralized Procedure
• Centralized Procedure
• Counseling and outlining strategies to obtain MA
• Preparation of documentation in CTD, eCTD, NeeS format
• Expert reports

 

Maintenance of Marketing Authorizations

• Type IA, IAN, IB and Type II variations
• Preparation and analysis of SmPc, PIL and Labeling
• MA renewal
• MA transfer

 

Readability tests of the package leaflet

Bridging studies