How can our biologics drug development program reach IND/CTA faster?

Move forwards to IND/CTA faster with Abzena.

The pathway to an investigational new drug (IND) application and clinical trial application (CTA) can be long, complex and costly. For over 20 years, Abzena have proven that we know what it takes to develop a successful biologics drug candidate — from early development to commercial launch.

Navigating from discovery to IND/CTA

When you reach your IND stage, one the biggest challenges is providing the extensive documentation that is required. The FDA or EMA requires a range of documentation, such as:

  • Chemistry, manufacturing and control (CMC) data
  • Pharmacology data
  • Toxicology data

With over 20 years of complex biologics and bioconjugates experience, we can help move your program forwards through this stage of development.