Our scope of intervention:
- Regulation of health products (drugs for human or animal use, medical devices, in vitro diagnostic devices, blood products, gene therapy products), cosmetics and phytosanitary products:
- Regulatory qualification of products
- Research / Clinical Trial
- Marketing authorization
- Market access (price, reimbursement, evaluation/revaluation)
- Promotion, communication, advertising
- Anti-gift and transparency
- Regulation of health activities and actors
- Rules of Practice for Health Professions
- Regulations applicable to health care institutions and medical biology laboratories
- Authorization and compliance with procedures related to the manufacturing, distribution, import/export and sale of human and veterinary health products.
- Regulation of E-Health activities:
- Telemedicine
- Connected health objects and health applications.
Our clients:
- Biotech and Medtech, pharmaceutical laboratories (human and veterinary), manufacturers of medical devices and IVDDs, home care providers, professionals and healthcare institutions, but also manufacturers of phytosanitary products.
They trust us
- We are advising a French Medtech in the implementation of its regulatory strategy and negotiation of contracts for rapid detection tests for Sars cov2 antibodies with its public institutional partners, customers and suppliers.
- We are assisting a family-owned pharmaceutical company on several regulatory issues, including the definition of its regulatory strategy in the face of a competing hybrid marketing authorization.
- We are counselling a manufacturer of homeopathic medicines in the context of the delisting of its products.
Good to Know
- The Life Sciences team works in collaboration with the firm's teams specializing in new technologies, data protection, intellectual property and capital operations to serve all of its life sciences clients' projects and issues.
- Bignon Lebray's Life Sciences practice has been distinguished in Décideurs Magazine's Health, Pharma & Biotechnologies rankings and has been ranked as a high-profile practice on several occasions.
