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Biotech

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.

Our expertise

We advise biotech companies across the full product lifecycle, from early-stage R&D and clinical development through to market access and post-market compliance. Our team has hands-on experience with the regulatory frameworks governing pharmaceuticals, veterinary medicines, plant protection products, human tissue, chemicals, and genetically modified organisms. We stay on top of evolving legislation so you can focus on innovation.

How we can help

Our work covers the full range of regulatory procedures that biotech companies encounter, from marketing authorisation applications and clinical research notifications to environmental risk assessments. Beyond regulatory support, we advise on commercial contracts, licensing arrangements, and due diligence in the context of financing rounds and M&A transactions. When regulatory issues arise, whether inspections, enforcement actions, or product recalls, we are ready to step in and assist.

Recent

Biotech Food and Feed Regulatory Compliance and Enforcement Blog

EU Biotech Act and Food and Feed Safety Simplification Omnibus: what’s in it for the food and feed sector?

December 2025 brought two major regulatory proposals from the European Commission: the first part of the EU Biotech Act and the Food and Feed Safety Simplification Omnibus. Together they promise regulatory sandboxes for testing innovative products, a broader advisory role for EFSA, tailored rules for genetically modified micro-organisms, and a move from time-limited to unlimited approvals for substances with proven safety records. For food and feed businesses, that translates into faster market access, lighter administrative burdens and more legal certainty, provided the underlying safety standards keep pace.

Biotech Healthcare Commercial Contracts Intellectual Property and Licensing Testimonial

Axon assists medical technology companies in structuring their collaborations with hospitals and universities. We draft and negotiate cooperation agreements that protect our clients’ IP while fostering innovation.

Biotech Food and Feed Due Diligence Regulatory Compliance and Enforcement Testimonial

Axon assisted a French VC company investing in a food tech start-up. We reviewed the target’s regulatory strategy under the EU novel foods framework, assessed its feasibility and outlined potential risks and how to mitigate these.

Biotech Food and Feed Regulatory Compliance and Enforcement Testimonial

Axon helped The Protein Brewery rename its novel food product. We proposed consumer-friendly alternatives to the European Commission, resulting in an approved name the client is very happy with.

Agriculture Biotech Food and Feed Regulatory Compliance and Enforcement Spin-out and Starter Advisory Testimonial

As a partner of StartLife, Axon assisted a feed company with the regulatory qualification of its technology. Our reasoned opinion serves as a key document for the company’s funding activities.

Biotech Food and Feed Commercial Contracts Intellectual Property and Licensing Testimonial

A Nordic company owns a proprietary technology for producing legume-based meat alternatives. Axon drafted technology licensing agreements and developed an IP strategy covering patents and trade secrets, with practical checklists for implementation.

Biotech Corporate, Governance and Boardroom Counselling Intellectual Property and Licensing Spin-out and Starter Advisory Testimonial

Axon regularly advises spin-outs from academic institutions on a wide range of topics. We make sure that the spin-out’s license agreement includes commercially and legally viable terms and is attractive to investors. In addition, we advise on the corporate structure of the spin-out, balancing the interest of the founders, the academic institution and all other stakeholders.

Agriculture Biotech Intellectual Property and Licensing Testimonial

Axon advised a Dutch joint venture, that is active within the agri-food and agricultural biotechnology sector, on the transfer of its assets to a German investment fund. The transferred assets involved patent rights, plant breeders’ rights, trade secrets and biological materials.

Biotech Pharmaceuticals Commercial Contracts Intellectual Property and Licensing Testimonial

Axon advised a stock-listed biopharmaceutical company on antibody licensing and technology transfer agreements with two major US-based pharmaceutical companies. The deals involved the grant of commercial rights to the licensor's proprietary antibody platform technology.

Biotech Corporate, Governance and Boardroom Counselling Financing and M&A Testimonial

Axon assisted a Dutch cultivated materials company in securing a EUR 22M Series A financing round. We advised on the transaction structure, investment documentation and related matters.

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