Pentara provides comprehensive regulatory support, guiding clients through the entire drug development process and preparing them for interactions with authorities like the FDA and EMA. This includes preparing briefing documents, writing questions, and providing support during critical meetings. We also guide clients on regulatory requirements, ensuring compliance and minimizing risks.
Our expertise is rooted in scientific rigor, ensuring that all submissions are built upon sound statistical methodology and independent analysis. We ensure that your data not only meets technical requirements but also presents the strongest possible scientific argument for efficacy and safety, leveraging our deep knowledge in specialized areas like neurodegenerative disease.
In situations where a trial's first pass encounters unexpected obstacles, whether a partial clinical hold, an urgent FDA submission deadline, or preliminary data that requires a strategic pivot, Pentara specializes in rescue study and regulatory remediation. We apply independent statistical oversight to quickly diagnose underlying design flaws, statistical issues, or data deficiencies. Our urgent response team prepares time-sensitive amendments, delivers rapid data analysis, and crafts the compelling documentation needed to get complex trials back on track and through the regulatory gates. This expert intervention is crucial for salvaging significant financial investment and accelerating the delivery of critical therapies.
Pentara also guides clients on regulatory requirements, ensuring compliance and minimizing risks.