Since 2005, we have been guiding our sponsors through the intricacies of the regulatory system both when dealing with national regulatory institutions and FDA or EMA. In addition to clinical trial approval, our goal is to help our clients develop and implement the most optimal registration strategy in order to speed up market access.
Secure swift and successful clinical trial approvals with Palleos. Our expert team navigates complex regulatory landscapes in Central and Eastern Europe, and demonstrates extensive experience with FDA and EMA submissions, including pre-IND meetings, scientific advice, NDA applications, and orphan drug designations. We ensure your study documents receive the necessary approvals from all relevant authorities and ethics committees, facilitating smooth clinical trial processes.
Palleos Medical Monitoring Services encompass medical surveillance of your trials by experienced clinicians to ensure patient safety and signal detection/interpretation. The Medical Monitoring service also comprises quality control and approval of your trial documents in order to comply with the ethical standards and regulatory requirements for clinical research. Futhermore, our medical experts provide training on specific medical topics.
“Operating in an environment with ever-evolving local and global regulatory platforms bears quite a few strategic, timeline and budget challenges. While these challenges cannot be disregarded or ignored, we do our best to make them manageable and contained. And being manageable means pursuing our clients’ best interests.”
Managing Director
