The leading pharma & biotech law firm based in Amsterdam, Genome Lawyers provides a tailored service to clients in the pharmaceutical and biotech industries. Founder Hanneke Later-Nijland specialises in EU and national regulatory life sciences law, and is also a trained pharmacist. This allows us to offer a unique perspective and industry expertise.

We assist, advise and litigate for global clients across the Netherlands, Switzerland, the UK, US and Canada, who come to us for our experience in regulatory issues, IP, clinical trials, compliance and much more. With a bespoke service that is designed to meet the needs of your organisation, we can help you through a wide range of challenges. 

Genome Lawyers has expertise in a wide range of issues relating to law and the pharmaceutical, the biotechnology and the medical devices industries, including:

• Assistance and possible administrative law review as to administrative penalties (bestuurlijke boetes) 
• Issues on the interface between regulatory & IP
• Interactions with the competent authorities, such as with the Inspectorate for Healthcare and Youth (IGJ), Medicines Evaluation Board (CBG-MEB), Central Committee Medical Research (CCMO), European Medicines Agency (EMA) and the RIVM
• Biotech: ATMPs advice, demarcation
• Issues concerning clinical trials and clinical trial agreements
• Transactional Regulatory Compliance Prognosis: assistance in M&A deals as to regulatory law
• Strategic advice, e.g. re compounding or collegial delivery
• Reimbursement, pricing, negotiating financial arrangements, lobbying
• Pharmaceutical adverting, complaints procedures
• Issues, advice and litigation concerning medicinal cannabis
• Functioning as an EU pharmaceutical law expert, e.g. in litigation
• Preference policy bids assistance

Dr. mr. Hanneke Later-Nijland, is the only lawyer-pharmacist with a PhD in the Netherlands. Therefore, she is a lawyer with an extraordinary, atypical background. Hanneke specialises in the EU and national regulatory life sciences law. She holds a PhD in pharmacokinetics and pharmacodynamics. Previously, she was an inspector for Clinical Trials and Pharmacovigilance with the Inspectorate for Healthcare (IGJ).

This rare background gives her a unique perspective and understanding of the life sciences sector. 

In her practice, Hanneke advises life sciences and healthcare clients and litigates on a wide range of issues. Areas of expertise cover marketing authorisations, reimbursement, compliance, pharmacovigilance, advertising issues, product liability, issues on the interface of IP and regulatory, and —finally — regulatory assistance in transactions. For the use of M&A or for the comfort of investors, Hanneke is able to provide tailor-made Transaction Regulatory Compliances prognosis reports. 

Hanneke is a university lecturer in Leiden and she publishes frequently on regulatory life sciences issues, such as new European legislation and the impact of recent judgments in the sector.