Expertise
The field of healthcare products and technologies, as well as the activities associated with them – whether related to research, development, manufacturing, distribution, or innovative services – is governed by particularly stringent regulations.
These rules evolve rapidly within both national and european legislative frameworks, involve the participation of numerous stakeholders, and require a cross-disciplinary approach combining scientific, industrial, organizational, and legal considerations.
Our expertise covers all key sectors of healthcare and life sciences, including pharmaceuticals and medical devices, substances of human origin (SoHO), clinical research, medical biology, personal data and health data, as well as relationships between industry stakeholders and healthcare professionals (annti-gift and, transparency laws). More broadly, it extends to all aspects of healthcare law, both from a regulatory standpoint and in terms of its operational implications.
Our team supports all stakeholders operating in this ecosystem, whether academic, industrial, or non-profit, including pharmaceutical and cosmetics companies, medical biology laboratories, research organizations, CROs, medical device manufacturers, healthcare institutions, entities operating health-related products or services, software editors, and industrial players developing innovative solutions or processes, as well as all project leaders seeking to enter this market.
Our role is to provide a structured legal framework, secure each step of the project, and facilitate interactions with the various stakeholders and competent authorities.
Our objective is to enable every project – whether technical, scientific, organizational, or digital – to operate within a clear, coherent legal environment tailored to its specific features.
Our Expertise
Determination of the applicable legal framework for healthcare products
- Analysis of product status (medical device, medicinal product, cosmetic, food supplement, borderline product);
- Identification of regulatory obligations according to the relevant category.
Legal support for research projects
- Qualification of the type of research (clinical trial, clinical investigation, research on biological samples, RIPH);
- Legal advice on applicable regulatory requirements;
- Structuring contractual relationships (consortium agreements, partnerships, investigator site agreements, material and/or data transfer agreements);
- Assistance in preparing regulatory submissions and implementing procedures with the relevant authorities or committees, such as the ANSM, national ethical committee, and the Ministry of research (CODECOH).
Putting healthcare products on the market
- Drafting and reviewing contracts;
- Legal assistance to ensure product compliance with regulatory requirements throughout its lifecycle;
- Support in dealings with health authorities and supervisory bodies (notified bodies, ANSM inspections, CNIL audits).
Legal support for projects involving health data processing and e-health projects
- Regulatory analysis of the project;
- Assistance in completing the regulatory formalities required to implement the project with the competent authorities (CNIL, Health Data Hub, etc.);
- Support in the creation and management of health data warehouses; access to and linkage with the SNDS;
- Drafting of the legal and contractual documentation required for project deployment;
- Overall legal safeguarding of the project framework.
