Advancing your compound into first-in-human clinical trials in the USA and Europe requires completion of an investigational new drug (IND) and clinical trial application (CTA), respectively. IND- and CTA-enabling studies comprise preclinical pharmacology, toxicology, metabolism and manufacturing studies that allow you to submit a formal application with either the FDA or EMA.
The specific IND/CTA-enabling GLP studies you need is unique to your drug candidate, its therapeutic indication, the study data and also the regulatory agency. The FDA and EMA have different regulatory requirements; therefore, it is vital to understand those differences so you can design and plan your IND/CTA-enabling studies accordingly. Because it’s common to file a drug application in both regions, strategically planning your IND/CTA-enabling GLP studies will help optimize your approach and spend.
Enjoy the benefit of our extensive experience in planning and executing the preclinical studies you need for a successful IND/CTA submission –getting you to FIH quickly and efficiently.