Our expertise

Clinical Trials

We advise a large number of companies and institutions active in pharmaceuticals, medical devices and foodstuffs on the interpretation and application of EU and national legislation regarding clinical trials, including privacy implications, trial insurance requirements, adverse events and healthcare professional interaction. The degree of specialisation in this field, enables us to vector in upcoming changes in the regulatory framework and provide practical solutions to legal, commercial and scientific needs.

In addition, we draft and negotiate all agreements pertaining to clinical trials, both from an industry driven and investigator initiated perspective as well as with or for CROs. We furthermore represent insurance companies in disputes and settlements with trial subjects based on the Decree on Compulsory Insurance and clinical trial sponsors in product liability claims.

Finally, we know our ways in academia through in-house legal work at university medical centres and thoroughly understand the way in which IRBs evaluate clinical trial protocols. We can therefore efficiently represent our clients before such IRBs when changes to clinical trial protocols need to be approved or when investigators have views that diverge from those of the sponsor.

Our services

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Regulatory

Life sciences regulation is international, complex and always changing. Our team makes sure that you...

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Compliance

The compliance stakes that a company may face in the life sciences field are high,...

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Intellectual property

Intellectual property rights are at the core of the life sciences industry. They are the...

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Commercial contracts

Whatever the activity, partnerships or business deal - commercial contracts are needed to ensure the...

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Due diligence

If a company wants to acquire another company, intends to grant a license, or wants...

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Financing

Companies in the biotech industry are highly dependent on funding in the form of equity,...

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Boardroom counselling

We know from experience that a fresh external view on strategic issues considerably benefits a...

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R&D and License agreements

Research and development and license agreements are essential in the life sciences field. From experience...

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Spinout contracts

We have coached numerous scientific founders and knowledge institutes during spinning out inventions and intellectual...

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Your business

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IVDs

Building on our thorough understanding of both the IVD sector and the (inter)national regulatory framework,...

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Medical Devices

Our internationally recognized medical technology practice advises leading established as well as startup innovative medical...

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Clinical Trials

We advise a large number of companies and institutions active in pharmaceuticals, medical devices and...

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Food

Axon Lawyers assists food business operators in all their needs regarding the manufacturing and marketing...

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eHealth and mHealth

In the fast expanding market for eHealth, mHealth and telemedicine, we provide our clients with...

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