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.
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Axon supports pharmaceutical companies in licensing their products across Europe and beyond. We draft and negotiate licence agreements tailored to each market, helping clients maximise the value of their intellectual property.
What distinguishes our lawyers is the ability to see the whole regulatory picture. We have assisted multiple clients, ranging from CROs to pharma start-ups to medical device manufacturers, in setting up GDPR compliance processes and agreements that allow for seamless interaction with other legal frameworks such as MDR and IVDR.
We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.
We have advised pharmaceutical companies with legal advice across the full product lifecycle, from early-stage development through to market authorisation and post-marketing compliance.
We have negotiated clinical trial agreements on behalf of several sponsors.
We regularly assist clients with pricing and reimbursement procedures in the Netherlands.
We have litigated in a pharmaceutical case concerning the validity of marketing authorisations.
We have assisted a large company in setting up a patient support program.
We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.