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Due Diligence

Before entering into a transaction or a collaboration with another party, it is essential to understand what you are dealing with. In life sciences, that is rarely straightforward. The value or risk of a counterparty is often concentrated in assets and arrangements that require specialist knowledge to assess properly: a regulatory approval that may be narrower in scope than it appears on paper, an IP portfolio with unresolved ownership questions, or supply chain arrangements that carry hidden compliance risks. Identifying these issues before you commit determines whether a deal or partnership delivers what you expect.

Our expertise

We combine deep knowledge of corporate transactions with sector-specific expertise in intellectual property, regulatory compliance, and the particular dynamics of life sciences companies. Because we advise life sciences companies on these areas on a day-to-day basis, we know what the risks look like in practice, where they tend to be hidden, and what they mean for the relationship or deal at hand.

How we can help

We conduct legal and regulatory due diligence tailored specifically to life sciences transactions and collaborations. Our review covers regulatory compliance and approval status under the Medical Device Regulation (MDR), the In Vitro Diagnostics Regulation (IVDR), and the Medicines Act, (pre)clinical data obligations, pharmacovigilance requirements, and post-market surveillance risks. On the IP side, we review licensing arrangements and identify encumbrances or restrictions that could affect the commercial viability of the transaction or partnership. Data protection compliance forms another core element of our review, encompassing GDPR obligations relating to health data processing and consent frameworks. We also assess corporate structures and key commercial agreements, including shareholding arrangements, corporate governance documents, existing obligations, and assignment restrictions that are relevant to the deal or partnership. Where we identify risks, we advise on how to reflect them in the structure through targeted warranties, indemnities and measures.

Recent

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.

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.

Due Diligence Testimonial

Axon regularly provides specialist due diligence support on a variety of corporate transactions in the life sciences sector.

Medical Devices Data Protection, (Cyber)security and AI Due Diligence Regulatory Compliance and Enforcement Testimonial

We have conducted regulatory due diligence on behalf of a private equity firm in connection with the acquisition of a medical device manufacturer, covering MDR compliance (including notified body certificates and post-market surveillance obligations), as well as data protection aspects.

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.

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

Axon acted on behalf of an investor in connection with their investment in a clinical-stage biotech company developing first-in-class therapeutics and diagnostics for fibrosis. We conducted legal due diligence on the target company and reviewed the transaction documentation on behalf of the investors.

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