Regulatory

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Our regulatory team masterfully apply critical thinking when defining the regulatory strategy.

They realise that generalisations such as ‘The FDA says’ or ‘The EMA says’ may not be solid and will help avoid the situation of untested generalisations. We have frequent dialogues with the regulators and can help you with the practical implications of regulations.

Axcellant regulatory team have built a strong reputation with global regulators and even our competitors use our regulatory services.

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Meet Axcellant at EANM 2024 in Hamburg

Axcellant is excited to announce our participation at the European Association of Nuclear Medicine (EANM) Congress in Hamburg from October…

We are delighted to share exciting news from our team at Axcellant!

Marking a significant achievement in our ongoing efforts to advance medical device research, we have successfully concluded a PMCF study…

Key Considerations for Initiating a Clinical Trial: A Comprehensive Guide

Initiating a clinical trial is akin to embarking on a voyage of discovery in the realm of medicine. This journey,…