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:

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Assistance and possible administrative law review as to administrative penalties (bestuurlijke boetes

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Issues on the interface between regulatory & IP

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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

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Biotech: ATMPs advice, demarcation

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Issues concerning clinical trials and clinical trial agreements

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Transactional Regulatory Compliance Prognosis: assistance in M&A deals as to regulatory law

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Strategic advice, e.g. re compounding or collegial delivery

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Reimbursement, pricing, negotiating financial arrangements, lobbying

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Pharmaceutical adverting, complaints procedures

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Functioning as an EU pharmaceutical law expert, e.g. in litigation

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Preference policy bids assistance

Pharma and Biotech law specialists in Amsterdam

Our Services

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.

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WHO WE ARE

SPEAKING ENGAGEMENTS