Updates

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.

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.

We have assisted a client in setting up a multinational data strategy, including advice on anonymisation of personal data and interaction product regulations and the upcoming high-risk regime under the European Health Data Space Act (EHDS Act) to help them continue innovating without endangering company confidential developments.

We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.

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

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.

On behalf of a medical device company, we reported a personal data breach to the supervisory authority and have advised on internal communication.

We set up procedures for multiple clients continues transfers of personal data beyond the EU, including to countries without an adequate data protection regime, for various purposes.

For a client conducting a multinational clinical investigation, we have drafted informed consent notices that allow for long term use of clinical research data beyond the confines of the study.

We have trained the entire regulatory team of a medical device company on understanding GDPR compliance in a clinical research setting.