Since 2005, we have been guiding our sponsors through the intricacies of the regulatory system both when dealing with national regulatory institutions and the 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 boasts 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.
Experience with FDA & EMA
In addition to the thorough knowledge of local regulatory specifics, we are proud of our solid track record in assisting our sponsors with global regulatory activities:
• Successful experience in conducting pre-IND meetings with the FDA
• Scientific advice meetings with the EMA
• Submitting NDA applications to the FDA
• Obtaining orphan drug status from the EMA & FDA
Palleos medical monitoring services:
“Operating in an environment with ever-evolving local and global regulatory platforms results in quite a few strategy, timeline and budget challenges. While these challenges cannot be disregarded or ignored, we do our best to manage and contain them. And managing them means pursuing our clients’ best interests.”
Managing Director
