We focus on pharma & biotech
Genome Lawyers are uniquely well-connected, serving your business in a pragmatic and effective way.
Advice & litigation for global clients
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
Functioning as an EU pharmaceutical law expert, e.g. in litigation
Preference policy bids assistance
Pharma and Biotech law specialists in Amsterdam
Genome Lawyers specialise in pharmaceutical and biotechnology law. Next to that, we assist medical devices companies. Based in Amsterdam, we serve clients across the globe. Our in-depth knowledge of the working practice of the regulatory bodies in the Netherlands, as well as across Europe, means we can provide rare insight and tailored advice. Our team is uniquely well-connected and committed to serving your business in a pragmatic and effective way.
With experience providing advice and litigation services for a wide range of global clients, we know how to deliver the solutions you need, so contact us today to arrange an initial consultation with our team.