The Regulatory Affairs Team at Regulis secured prompt approval of clinical trial applications (CTAs) and maintained a consistent protocol to ensure the data will support a US NDA.
A US-based company were looking to conduct a randomised, controlled, phase III, multi-centre clinical trial to assess the efficacy, safety and pharmacokinetics of a medicinal product in patients with life-limiting melanoma. Given the nature of the condition which the trial is intended to treat and that the study results would be pivotal data for a US NDA and EU MAA, rapid clinical trial approvals were crucial. The company therefore also required a partner with specialist EU Regulatory Affairs knowledge to manage the country-specific submission requirements and with local affiliates based in the target countries.
Using our significant experience of interacting with regulatory authorities, Regulis was able to work with each Competent Authority to compile robust responses to questions, and justifications for key aspects of the trial design. In addition, our local consultants were able to submit the applications via online submission portals (in local language) ensuring a rapid submission process.
Regulis rapidly gained clinical trial approvals, successfully maintaining a harmonised study design that would meet FDA’s requirements. Regulis provided expert advice based on recent practical experience, to guide through the complex regulatory processes in each member state.
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