Biopharmaceutical – Registration Clinical Pharmacology Package
To support your compound Registration, Aepodia provides services to design and implement your Biopharmaceutical (CTD 2.7.1) and Clinical Pharmacology Plan (CTD 2.7.2).
Pilot QTc studies are conducted in order to optimise the sample size and to select the adequate dose of the definitive QTc studies (ICH E14).
Our excellent project management and our Phase 1 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 «registrability» of your data.
