Regulatory submission package

To support your compound Registration, Aepodia provides services to design and implement your Biopharmaceutical (CTD2.7.1) and Clinical Pharmacology Plan (CTD2.7.2).

Pilot QTc studies are conducted in order to optimize the sample size and select the adequate dose of the definitive QTc studies (ICH E14).

Our excellent project management and our Phase I Units network allow us to manage parallel trials to implement your plan within optimal and competitive timelines.

Aepodia study coordinators, monitors, and quality staff ensure the quality and ability to register your data.