Wim is an EU regulatory partner who focuses on the life sciences sector.
Wim helps pharmaceutical, medical device, cosmetics, and food companies navigate the regulatory process in Europe throughout the life cycle of their products – from planning and development to approval and marketing, and through to enforcement and ongoing compliance. His work has been recognised by The Legal 500 in its 2024 list of notable EU Regulatory: Pharma, Medical Devices, and Biotech practices.
This includes advising clients on a broad range of regulatory issues, such as regulatory pathways, product classification, marketing authorisations, CE marking, clinical trials, product, GxP/QMS requirements, internal compliance processes and procedures, advertising and promotion, HCP/HCO interactions (including fraud and abuse), market access, adverse event reporting and recalls, and digital health. He also assists clients with regulatory due diligence evaluations regarding the compliance status of acquisition targets in the life sciences sector, as well as post-acquisition integration.
He frequently works with Reed Smith’s U.S. FDA team to provide equivalent advice on EU regulations to the firm’s clients in international matters.
As a natural corollary of his regulatory practice, Wim has developed substantial experience in drafting and negotiating industry-specific agreements, including contract manufacturing, development and commercialisation, supply, quality and pharmacovigilance, distribution, and other related agreements (e.g., CTA, CRO, MSA, MTA, and API).
Wim has represented clients before EU and national regulatory agencies in investigations and enforcement matters. This work also includes carrying out internal audits, developing corporate compliance programmes, and assisting with supply chain and product liability claims.
In addition to his life sciences practice, Wim also advises more generally on EU market access matters in multiple industries, such as consumer products, industrial machinery, e-commerce, technology, and manufacturing, and he is a core member of the firm’s Retail and Consumer Goods Group. This work includes counselling on product standards (safety, health, and environment), regulatory compliance approvals (including CE marking, packaging, and labelling), cross-sectoral requirements (e.g., materials and waste management, sustainability, and carbon neutrality), and internal market issues. He advises on the legal, practical, and procedural aspects of EU law-making, engaging with EU institutions to anticipate, understand, and influence policy and the legislative and regulatory developments that impact clients’ businesses.
