Expertise

Regulatory advice

• Regulatory audit and diagnosis: mapping of applicable obligations (marketing authorization, CE marking, labeling, claims, safety data sheets, etc.), identification of discrepancies and action plans.
• Monitoring and anticipation: analysis of new regulations (directives, regulations, national laws, implementing texts, ISO standards, ANSM/EFSA recommendations, ECHA, etc.) and support in adjusting internal processes.
• Authorizations and technical files: Preparation and submission of authorization applications (MA, CPNP notifications, DGCCRF declarations, CE marking, etc.), drafting and proofreading of technical files, safety reports, and clinical or toxicological studies.
• Contracts: distribution, licensing, raw material supply, and R&D partnership contracts, particularly with regard to liability, warranty, vigilance, and quality clauses.
• Implementation of quality and vigilance systems: development of internal procedures (HACCP, GMP, good clinical practices, pharmacovigilance, material vigilance, cosmetovigilance, nutrivigilance).
• Crisis management and product recalls: development of crisis management plans (withdrawal/recall procedure, crisis communication, liaison with health authorities). Strategic advice to limit legal and reputational impacts.
• Analysis of claims, presentation, and labeling

Investigations and inspections by authorities

• Preparation for inspections: implementation of an “inspection kit” (file for receiving injunctions, inspection log, emergency procedures). On-site support during inspections.
• Management of documentation and requests for information: restructuring and proofreading of all requested documents (test reports, analysis certificates, safety data sheets, clinical protocols, etc.). Drafting of written responses to questionnaires and formal notices.
• Negotiation and strategy with the authorities, post-inspection follow-up and litigation: analysis of the inspection report or minutes and assessment of possible next steps (informal appeal, judicial appeal, request for lifting of sanctions). Representation before administrative authorities and, where applicable, before administrative or judicial courts to challenge decisions (suspension, fines, seizure of batches).

Litigation

• Representation before administrative courts: Appeals against decisions of the ANSM, DGCCRF, DGS, DREAL, EFSA: suspension of orders, annulment of administrative decisions, contestation of sanctions.
• Representation before the courts: Product liability and fault-based liability
  • Civil actions: day-to-day management of large-scale serial cases and isolated cases involving product liability or fault.
  • Criminal proceedings: defense in coordination with criminal lawyers and technical experts.

We have developed an international network of scientific experts to assist us (toxicologists, consulting firms, pharmacists, university professors, etc.).