Between progress and innovation, the healthcare sector is faced, both nationally and internationally, with regulations that are both complex and constantly evolving. Our insight allows us to shape solutions that help you accomplish your projects, by taking into account their legal and economic stakes.
Our team of lawyers advises and represents, throughout the world, major players in the human and animal health, pharmaceutical, cosmetics, medical devices and biotechnology sectors.
Our expertise accompanies you at all levels of the health product value chain:
- securing design, R&D, technology transfer (public to private)
- placing on the market, pricing and repayment conditions
- relations with administrations and regulatory authorities
- relations with suppliers, distributors and consumers.
We are also involved in fundraising and tax structuring of the activities of healthcare manufacturers and in securing their relationships with healthcare professionals, patients, research organisations and foundations.
Finally, backed by technical and scientific partnerships, DS Avocats assists its clients in matters of compliance and quality of healthcare products in order to offer responsible and creative solutions.
The healthcare product life cycle
- Protection and development of intangible assets (IP and data)
- Marketing authorisations
- Clinical Trials
- EU certification and trademarks
- Relationship with regulatory authorities for market access
- Crisis and sanitary risk management (pharmacovigilance, material vigilance, cosmetovigilance)
- Healthcare Product Recall
- Digital health
The price and value of the healthcare product
- Pharmaceutical taxation
- Elaboration and negotiation of public/private contracts
- Validation and drafting of R&D partnerships
- Health data valuation and health data protection (GDRP)
The marketing of the healthcare product
- Distribution, registration and traceability
- Negotiation and drafting of contracts for the manufacture, distribution/sale of healthcare products and drafting of general terms and conditions of sale.
- Assistance with hospital public procurement contracts (responses to calls for tenders and contract performance)
- Relations with healthcare professionals (DMOS, transparency, DGCCRF / DDPP controls, criminal liability risk prevention)
The business management of the healthcare product
- Incorporation and structuring of companies
- Merger control
- Joint ventures / strategic alliances, asset disposals, M&A, private equity
- Assistance, advice and planning in the area of contributions and taxes that are specific to the pharmaceutical industry