Wim is an EU regulatory partner who focuses on the life sciences sector.
Wim helps pharmaceuticals, medical devices, 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, to enforcement and ongoing compliance. His work has been recognized by Legal 500 on 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 pathway, product classification, marketing authorizations, 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 events 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 science sector as well as post-acquisition integration.
He frequently works with Reed Smith’s U.S. FDA team to provide equivalent advice with respect to EU regulations to firm clients on international matters.
As natural corollary of his regulatory practice, Wim has developed substantial experience 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, 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 programs 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 equipment, media, technology, and manufacturing. This work includes counseling on product standards (safety, health, environment), regulatory compliance approvals (including CE marking, packaging, and labelling), cross-sectoral requirements (e.g. materials and waste management, sustainability, carbon neutrality) and internal market issues. He advises on both the legal and the practical/procedural aspects of EU law-making, engaging with EU institutions to anticipate, understand, and influence policy and the legislative and regulatory developments which impact clients’ businesses.
