Regulatory & Pharmaceutical Strategy
Atessia answers all your questions about your portfolio of health products.
Regulatory positioning of health products: medicinal products, medical devices (MD), food supplements, biocides and cosmetics
Regulatory strategy for registering chemical, plant-based, biological and biotechnological drugs in innovative therapies
- Determining the legal basis of the application according to the amended Directive 2001/83/EC
- Determining the type of procedure: centralised, decentralised, mutual recognition or national
Advice on national or European conduct of regulatory procedures (MRP, repeat use, CP)
Advice on the MA dossier content according to the application type and registration procedure
Advice on changing the legal status of medical devices and medicines (non-prescription, over-the-counter)
Further information
To meet your needs as closely as possible, Atessia offers year-long consultancy subscription packages:
Regulatory and pharmaceutical strategy assistance can meet your team’s needs throughout the year by consulting with Atessia.