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Pharmaceuticals

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.

Find your lawyer Our expertise

Our expertise

We go beyond compliance. We help pharmaceutical companies strategically integrate regulatory requirements into their business models. Whether the question concerns marketing authorisations, data exclusivity, advertising compliance, or interactions with health authorities, we provide legal solutions that facilitate innovation and risk mitigation while keeping commercial strategies effective.

How we can help

We advise on centralised, decentralised, and national approval procedures, and on compliance with the Clinical Trials Regulation, lawful data collection and ethical requirements for pharmaceutical research. We support pharmacovigilance obligations, adverse event reporting, and post-market surveillance. On the manufacturing and distribution side, we advise on GMP and GDP compliance, supply chain oversight, data exclusivity, and supplementary protection certificates. We help you navigate pricing and market access regulations and ensure that your marketing and promotional materials meet applicable legal requirements, including the rules on financial interactions, sponsorships, and inducements. When enforcement issues arise, we assist in inspections and compliance reviews, advise on product recalls and crisis management, and challenge enforcement actions and regulatory penalties.

Our pharmaceuticals specialists

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Carine van den Brink

Partner and attorney-at-law

  • Commercial & IP
  • Corporate

Erik Vollebregt

Partner and attorney-at-law

  • Regulatory
  • Litigation
  • Commercial

Karin Verzijden

Partner and attorney-at-law

  • Regulatory
  • Commercial & IP
  • Litigation

Stijn Gijsbers

Attorney-at-law

  • Regulatory
  • Litigation
  • Commercial

Judith de Wilde

Attorney-at-law

  • Regulatory
  • Litigation

Cécile van der Heijden

Senior legal counsel and attorney-at-law

  • Regulatory
  • Litigation
  • Commercial

Maartje Hop

Attorney-at-law

  • Regulatory
  • Commercial & IP

Max Luijkx

Attorney-at-law

  • Corporate
  • Commercial

Max Baltussen

Attorney-at-law

  • Commercial & IP

Jilles van der Hoek

Attorney-at-law

  • Regulatory
  • Litigation

Jasmin Buijs

External legal counsel

  • Regulatory

Inga Szweryn

Attorney-at-law

  • Corporate
  • Commercial
  • Regulatory

Menno Knaven

Attorney-at-law

  • Corporate
  • Commercial

Recent

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Food and Feed Medical Devices Pharmaceuticals Due Diligence Testimonial

Axon regularly acts as a sub-contractor for leading international firms to assist in regulatory due diligence in our fields of expertise: pharma, medical technology and food.

Pharmaceuticals Commercial Contracts Intellectual Property and Licensing Testimonial

Axon supports pharmaceutical companies in licensing their products across Europe and beyond. We draft and negotiate licence agreements tailored to each market, helping clients maximise the value of their intellectual property.

Healthcare Medical Devices Pharmaceuticals Data Protection, (Cyber)security and AI Testimonial

What distinguishes our lawyers is the ability to see the whole regulatory picture. We have assisted multiple clients, ranging from CROs to pharma start-ups to medical device manufacturers, in setting up GDPR compliance processes and agreements that allow for seamless interaction with other legal frameworks such as MDR and IVDR.

Healthcare Pharmaceuticals Due Diligence Regulatory Compliance and Enforcement Testimonial

We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.

Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have advised pharmaceutical companies with legal advice across the full product lifecycle, from early-stage development through to market authorisation and post-marketing compliance.

Pharmaceuticals Commercial Contracts Testimonial

We have negotiated clinical trial agreements on behalf of several sponsors.

Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We regularly assist clients with pricing and reimbursement procedures in the Netherlands.

Pharmaceuticals Litigation Regulatory Compliance and Enforcement Testimonial

We have litigated in a pharmaceutical case concerning the validity of marketing authorisations.

Healthcare Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have assisted a large company in setting up a patient support program.

Diagnostics Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.

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