The Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) is responsible for assessing the benefits and risks associated with the use of health products throughout their life-cycle. ANSM assesses the safety, efficacy and quality of these products and must balance patient safety with access to novel therapies.Our experienced regulatory team remains up to date with the French regulatory landscape.
Advice and interpretation of French regulations
Interaction and meetings with the French Authorities (ANSM)
Regulatory support for clinical trials
Early access programme (ATU)
You can rely on the experience and expertise of our consultants for providing advice and efficient implementation of your ATU projects (nominative and cohort). We can assist you in the following:
Provision of ad-hoc advice or responses to specific questions, including strategy and/or positioning of your ATU projects.
Preparation or review of your ATU application including the protocol for therapeutic use (PUT)
Submission of ATU dossiers to ANSM and follow up until ATU is granted
Pre-launch activities for the management of your ATU programmes: setting up a dedicated ATU team (cellule ATU), assigning toll-free phone/fax numbers, creation of a database for the management of the ATU
Day-to-day management of your ATU programme: Patient inclusion and follow up, validation of the pharmacist orders, processing and capturing all necessary data
Generation and submission of ATU periodic reports
Advice on “Exploitant” responsibilities
We can provide advice and support for your “Exploitant” activities in France.
Support to obtain and maintain Exploitant license in France including processes and procedures.
ANSM mock-inspection of your Exploitant site
Writing of product quality reviews
Provision of Deputy Qualified Person/Head Pharmacist (Pharmacien Responsable Intérimaire)