Despite the increasing range of guidance documents available, and the best efforts of those involved in producing them, product development sponsors are often faced with challenges that require a “case-by-case” and a “scientific-based” approach.
Stuart Mudge
2004 – ERA news
Consulting with EU experts: Why, When & How
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2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
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The EU CTR (Clinical Trials Regulation) no. 536/2014 became effective on 31 January 2022. Among all the challenges, Sponsors often…
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The marketing authorization is a key step in the product development pipeline of any healthtech product. It involves the assessment…
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If you are developing a drug for a rare disease in the European Union, you may qualify for an Early…
