STRATEGY AND LITIGATION
— Assistance in defining regulatory strategy and negotiating with health authorities
— Pre-litigation negotiation with health authorities
— Prevention and management of administrative litigation related to market access
— Litigation against health authorities’ decisions relating to price and reimbursement of health products (challenging the pricing decision, challenging a non-reimbursement decision (list inscription refusal or delisting), compensation claims against health authorities)
— Litigation against health authorities’ decisions (administrative decisions relating to medical devices’ marketing or medicines’ marketing authorizations (MA), MA withdrawal and suspension, products recall, administrative sanctions, and penalties following inspections/authorities’ controls)
— Civil and administrative litigation for defective product liability.
REGULATORY AND COMPLIANCE
— Assistance to ensure the compliance with regulations applicable to health products (drugs, medical devices, cosmetics, food supplements, borderline products)
— Legal qualification of health products and applicable scheme
— Regulatory advice on market access (approvals, product marketing authorization, early & compassionate access, pricing, reimbursement)
— Advice on health product promotion activities (risk assessment and validation of promotional materials and claims)
— Support for the implementation of anti-gift and transparency rules, compliance standards and good practices
— Implementation and/or audit of internal procedures (anti-gift and transparency, GDPR, contracting SOP, etc.)
— Regulatory advice related to vigilance obligations
— Definition, audit of internal procedures.
— Assistance to foreign companies to evaluate the possibility and define the means to access the French market for all types of products in the Life Sciences sector
— Advice and support in the implementation of early access and product marketing authorization
— Regulatory advice on pricing, financing and reimbursement of health products
— Support in defining the economic strategy and in the negotiation of pricing requests as well as registrations on the reimbursement lists
— Support in the process of price agreements with health authorities
— Management of disputes with the health authority on decisions related to pricing and registration on reimbursement lists.
— Drafting, verification and validation of contracts specific to the Life Sciences industries
— More specifically, drafting of pharmaceutical agreements (marketing, distribution, SDEA, quality (QTA) outsourcing, subcontracting, transfer of marketing authorizations)
— Advice on price agreements with the economic health authority – CEPS
— Drafting of sponsorship, partnership, cooperation and donation agreements
— Drafting of contracts between industry and health professionals in compliance with legal and ethical rules.