Where law meets life sciences

The biotechnology sector sits at the intersection of science, innovation, and regulation. Whether you are active in pharmaceuticals, medical devices, agricultural biotech, or industrial applications, bringing a biotech product or process to market requires navigating a complex web of EU and national rules, from clinical trials and marketing authorisations to chemicals regulation and environmental requirements. Understanding this regulatory landscape is essential to turning scientific breakthroughs into commercial reality.

Companies active in the chemicals, plastics, and coatings industries operate in a highly regulated environment, where substance registration, product safety, sustainability, and environmental impact are all subject to scrutiny. Compliance with EU chemicals legislation, including REACH, POPs, RoHS, CLP, and the Biocidal Products Regulation (BPR), as well as the direction set by the Chemicals Strategy for Sustainability, is essential for market access and risk mitigation. Additional rules on PFAS, microplastics, food contact materials, and industrial coatings add further complexity, making it essential to stay ahead of a fast-evolving regulatory landscape.

The cosmetics industry is subject to a detailed and evolving regulatory regime designed to ensure product safety and transparent consumer information. The EU Cosmetics Regulation sets strict requirements for product composition, safety assessments, labelling, and advertising. At the same time, the boundaries between cosmetics and other product categories, such as medical devices, biocidal products, and pharmaceuticals, are not always clear-cut, making proper qualification of a product a critical first step.

In vitro diagnostics are a species of medical devices that sit in a regulatory space of their own. Since the In Vitro Diagnostics Regulation took full effect, a far larger share of tests — including companion diagnostics, laboratory-developed tests and much in between — now demands notified body involvement, robust performance evidence and continuous post-market monitoring. Whether you are building a novel biomarker platform or adapting an established assay for clinical use, the underlying task is the same: turning scientific and analytical performance data into technical documentation that satisfies both the IVDR and the notified bodies reading it.

Digital technology is transforming healthcare, but with innovation comes regulatory complexity. Solutions that collect health data, support clinical decisions, or interact with patients may not only qualify as medical devices under the Medical Device Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR), but also trigger obligations under the AI Act, European Health Data Space Act (EHDS Act), GDPR, or bring a company within the scope of Dutch healthcare law. Getting this right from the outset is not just a legal formality; it is a commercial necessity.

The food, feed, and pet food sectors are governed by a comprehensive and highly detailed regulatory framework. From novel foods and additives to flavourings and medical foods, as well as the classification of products at the boundary between foodstuffs and health products, the rules that apply to your product determine how it can be developed, marketed, and sold. Staying ahead of these rules is key to bringing your product to market successfully.

The healthcare sector sits at the heart of life sciences. Whether you develop medical devices, pharmaceuticals, diagnostics, or digital health solutions, at some point your product or service will enter the healthcare system, and with that comes a layered set of legal obligations. Companies engaging with hospitals, healthcare professionals, and healthcare insurers must navigate Dutch healthcare law, public procurement rules, inducement and anti-bribery frameworks, and insurance reimbursement conditions. For some companies, the way they operate may even trigger classification as a healthcare provider under Dutch law, with far-reaching regulatory consequences.

Few regulatory regimes ask as much of a product as the Medical Device Regulation. The MDR governs a device across its entire life cycle — clinical evaluation, technical documentation, conformity assessment and post-market vigilance — and applies alike to a class I wheelchair and a software-driven implant. The real difficulty is seldom any single requirement. It lies in keeping pace with shifting legal requirements, notified body expectations, holding a device compliant across every market in which it is placed, and managing the seams where the MDR meets the horizontal regulations now layered over it, such as the Batteries Regulation and the Packaging and Waste Regulation.

The pharmaceutical industry operates in one of the most complex regulatory environments in the world. From R&D to marketing authorisation and post-market surveillance, companies must comply with a stringent framework of EU and national regulations, including the national implementations of the Medicines Directive, the Clinical Trials Regulation governing research with medicinal products, GMP and GDP standards, pharmacovigilance obligations, and pricing and reimbursement rules. Marketing and promotional activities add further complexity, with strict rules on interactions with healthcare professionals and permissible advertising under the Dutch Medicines Act and industry codes. Managing all of this requires a legal partner who understands the sector from the inside.