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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Newsroom

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,…

Completion of a significant clinical study

Our team at Axcellant is proud to announce the completion of a significant Post-Market Clinical Follow-up study. This study was…