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

  • 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

Download the document "L'enregistrement des médicaments humains et vétérinaires"

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.