As a fully regulated sector, health products are subject to strong regulatory constraints at every stage of their life cycle, requiring precise and cross-disciplinary expertise, integrating practical issues and economic realities.

A RECOGNIZED PRACTICE in pharmaceutical regulatory affairs

With more than 10 years of experience at the ANSM, in international laboratories and in a firm dedicated to the health industries, the richness and complementarity of the practice of ELSI's partners give the firm a sharp and recognised know-how, anchored in the operational realities ofits clients on all the regulatory issues of health products.

Nourishing their practice and their practical and renewed vision of the sector, ELSI's partners are constantly mobilising to give the firm a singular competence, at the service of its clients, through :

- Their active participation in the Comité de protection des personnes (CPP), giving the firm a particular and practical competence in the field of clinical trials and investigations, which is essential in these cases with high ethical, legal and regulatory stakes,
- Their constant involvement in thetraining
- Their partnership with national and international networks of legal, technical-regulatory and medico-economicexperts, with whom they collaborate in the review, framing and implementation of global regulatory strategies for complex and high-stakes cases.

The reactivity and assistance provided in the follow-up and management of administrative follow-up, controls and inspections by the health authorities and reputational risk also give ELSI its reputation.

our approach: to be partners and allies on a daily basis

Anchored in sectoral practice and resolutely accessible, ELSI's lawyers cultivate a modern approach and field expertise to meet the expectations of its French and foreign clients as closely as possible.

In this respect, ELSI offers tailor-made support based on a dual approach combining advice and litigation, integrating risk analysis and anticipation, with the desire to provide a clear and strategic vision of all the regulatory issues encountered.

As a true partner of its clients on a daily basis, the firm offers integrated legal and regulatory advisory solutions, adapted to each environment, in the form ofsubscriptions andoutsourcing of certain activities such as the management of anti-gift and transparency procedures in the health sector, which are highly profitable for the company.

These solutions also take the form of support and/or representation in regulatory procedures before the authorities (LLPR registration, CFS, etc.).

Our main areas of intervention

  • Qualification / Borderline products
  • Medicines, medical devices, in vitro diagnostic devices, vaccines, herbal specialities, food supplements and other products
  • Health claims
  • Vigilance
Market access strategy
  • Early access
  • Marketing authorisation: positioning, support during evaluation procedures, re-evaluation, with health authorities (ANSM, CHMP, PRAC), contradictory procedures and challenges to marketing authorisations
Prices & Refunds
  • Assistance and support for admission to reimbursement and price negotiation with the health authorities (HAS, CT, CNEDiMTS, CEPS)
  • Price/volume agreements
  • Registration on the lists of medecines that are eligible for reimbursable
  • Registration on the lists of products that are eligible for reimbursment, identification of generics lines
  • Assistance and support during re-evaluation procedures
Advertising, Information & e-communication
  • Qualification
  • Advertising visa and control
  • Financial penalties
Anti-gift law & health transparency
  • Audit
  • Agreements
  • Subcontracting
Establishments (opening, inspection by health authorities and competent directorates)
  • Support for the preparation, conduct and management of the aftermath of an ANSM inspection
  • Support and implementation of shortage management plans (SMP) and management of stock shortages
  • Responsibilities of the Responsible Pharmacist (RP)
Health policy:
contradictory & contentious
  • Advice and support during contradictory procedures:
    - Injunctions, health policy decisions (DPS), unfavourable decisions (MA, advertising visa, suspension, withdrawal of marketing of MDs, cosmetic products etc.)
    - Financial penalties
  • Contestation of sanitary police decisions: appeals & litigation (summary proceedings, proceedings on the merits)
  • Regulatory audit
  • Drafting of quality and regulatory procedures
Health data
  • Identification of personal data
  • GDPR compliance
  • Personal data policy
  • Securing contracts
  • Support for digital projects

Discover our other expertise & Services


Contract law, commercial, advertising, distribution, restrictive practices, anti-competitive practices



Commercial litigation, defective products, appeals against authorities' decisions, communication & crisis management


Personal data - Health data

GDPR, CNIL methodology, health data hosting
securing contracts, support for digital projects



Legal and regulatory updates, skills upgrading, find out about all our customised training offers


Anti-gift & transparency

Our outsourcing offer, the subcontracting of your anti-gift activities & health transparency


CONSULTING & subcontracting

Subscription to regulatory advice, audit packages, find all our subscription and subcontracting offers.


interim management

Transformation, temporary surge, implementation of new processes or crisis management



Contact us