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 new chemical, plant-based, radiopharmaceutical, biological, biotechnological and advanced therapy medicinal products, as well as new therapeutic indications
- 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)
Advice on conduct of regulatory procedures and assistance with French and European competent authorities
- 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
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.