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Johnathan Akers, Masters of Clinical Research

Regulatory Affairs Specialist
Independent Regulatory Affairs Professional
Apex, North Carolina, United States

Johnathan Akers is an EU Clinical Trial Regulation Specialist with a Master’s in Clinical Research from Ohio State University in the United States. Since beginning his regulatory career in 2019, Johnathan has specialized in the European Clinical Trial Regulation (EU CTR) and Clinical Trial Directive, focusing on submissions for drugs, medical devices, and combination products. He supports sponsors in navigating the complexities of EU regulatory frameworks, ensuring compliance and facilitating the transition of studies to the updated EU CTR (EU No 536/2014).

Johnathan’s expertise encompasses diverse regulatory environments across EU member states, with a focus on dossier preparation, agency interactions, and optimizing trial applications. By developing robust compliance strategies and streamlining submission processes, he works to mitigate compliance risks while aligning with local standards.

Committed to proactive regulatory excellence, Johnathan emphasizes collaboration to enhance operational efficiency and ensure quality outcomes. His work is dedicated to advancing strategies that support clinical trials and product submissions with the highest standards in regulatory affairs, contributing to both sponsor success and patient safety.

Disclosure information not submitted.

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