Expertise
LexCase’s teams have acquired extensive expertise in certain business sectors, in particular with regard to sector-specific practices and regulations.
Lifesciences
The Firm advises and assists its French and international healthcare industry clients throughout the life cycle of their products: from clinical trials to post-marketing litigation, including product liability litigation and litigation with health authorities, thanks to LexCase’s team of lawyers with interrelated expertise. Through our previous experience as in-house lawyers in the health and pharmaceutical sectors, and frequent contact with the French health authorities, regulators, courts, tribunals and specialist commissions, we have intimate knowledge of the actors in this field and detailed experience of relevant procedures, enabling us to manage all your legal issues effectively.
Our team has expertise covering all types of health products and other regulated products :
- Drugs, Medecines and Vaccines
- Medical Devices and IVDs
- Cosmetics
- Food supplements
- Frontier products
- Foods for special medical purposes
- Biocides
- Connected Health Solutions
Practices areas :
- R&D and pharmaceutical patents / Clinical trials
- Marketing : marketing authorisation, CE marking (new medical device regulation), definition of borderline products
- Market access : price & reimbursement, early access to medecine scheme
- Anti-bribery, gift regulation & transparency
- Business structures, projects or companies
- E-health : telemedicine, software, websites, data (GDPR), quantified self tracking (remote medical services)
- Contracts with business partners : distribution, subcontracting, national and international marketing
- Hospital public procurement and legal challenges to awards
- Promotion and advertising of medical product information
- Advice and assistance in relation to regulatory inspections
- Vigilance : drafting of appropriate tools / assistance in determining and defining processes
- Health product liability, class actions, image risk management
- Negotiation with authorities, medecine and health regulatory agency decisions
- Commercial and competition law disputes between business operators in the sector
Our Strengths
We are referenced by industry federations (SNITEM, FEBEA, COMIDENT) and actively collaborate with associations in the health field. In particular, we chair the working group on medical device advertising of the AFAR (French Association of Regulatory Affairs). As French representatives of the Blue Conference (a multi-juridictional network of specialist European law firms in the health sector), listed by Chambers & Partners, LEGAL 500 and Décideurs rankings, we also have a large network of international partners, experts in health law.
Responsable(s) du Département Lifesciences
