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, repeat-use or national

Advice on product innovation to obtain marketing authorisation, early access/compassionate use, orphan designation

Advice for changing prescription or delivery status of a medicinal product (OTC, open access)

  • Scientific advice and protocol assistance
  • Administrative eligibility and validation
  • Responses to LoQ and LoOI (quality, non-clinical and clinical)

Advice on borderline products (medicine, medical device, biocide, food supplement, cosmetic), especially on changing the legal status of medical devices and medicinal products

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.