Capitalizing on the experience of its partners in health authorities, pharmaceutical companies and law firms dedicated to the health industries, ELSI has developed a sharp expertise and a recognized practice on regulatory issues and problems, in their economic, commercial and competitive context, thus giving it a transversal approach and mastery of the pharmaceutical sector.
As a player in the field of pharmaceutical law, ELSI has extensive experience in the health industry and assists its clients in the development, negotiation, implementation and protection of their commercial policy and economic activities.
With its particular expertise in administrative law applied to health products, ELSI assists its clients in matters related to market access, pricing and reimbursement (Market Access) and advertising of health products, as well as in all procedures related to inspections. Our team assists operators in their dealings with the health authorities.
In addition to the regulatory aspects, ELSI is also involved in liabilityissues.
Regulated by the provisions of Directive 2001/83/EC of 6 November 2001 and Regulation (EC) 726/2004 of 31 March 2004, transposed into the Public Health Code, the marketing of medicinal products is subject to a very strict regulatory framework from the early stages of their development until they are actually placed on the market and monitored post-marketing.
Its rules adapt and evolve according to the different types of products concerned, implying in particular compliance with specific national or European procedures, specific early access conditions, the establishment of specific vigilance monitoring, and controlled communication, which must be taken into account both in the market access strategy and throughout the product life cycle. Pharmaceutical law also sets the pace for the life of pharmaceutical establishments, imposing a specific regulatory framework depending on the activities carried out: including authorisation to open, the presence of a pharmacist in charge, a pharmacovigilance officer, compliance with good practice, accompanied by permanent control by the national and European health authorities through inspections, giving rise to specific procedures (including injunctions, suspensions of authorisation and financial penalties).
The pharmaceutical industry is constantly evolving and has to adapt to new rules, such as the early access reform and the anti-gift and transparency system, while at the same time facing market issues and the implementation of a customised commercial, distribution and competition policy.
The constraints linked to the sector imply mastering the regulatory framework of medicinal products' regulation and understanding its technical and scientific specificities, as well as its economic and commercial issues. Specialised in pharmaceutical law, ELSI assists its French and foreign clients, pharmaceutical companies, MA holders, manufacturers, biotechs, pharmaceutical operators, clinical research companies (CROs), wholesalers and other economic operators, in advising, strategising, and securing the legal and regulatory aspects of all aspects of the life cycle of their products and activities, both as advisors and in litigation.
