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

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.