FAST-TRACKED DEVELOPMENT, DESPITE BEING A BCS CLASS IV DRUG

Poor bioavailability, an even greater risk of costly delays and holdups

Learn how Evotec’s IND-enabling package helped a small US biotech quickly overcome formulation development challenges and achieve regulatory submission in only 14 months.

Key points in our case study:

  • Evotec’s INDiGO IND-enabling package helped a small US biotech expedite regulatory submission of their BCS class IV drug in just 14 months
  • A robust regulatory data package was delivered on schedule and within budget, despite complex bioavailability issues
  • Evotec’s integrated approach ensured rapid decision-making and right-first-time results, giving the sponsor the competitive edge

Generating a quality data package against a demanding timeframe can be a challenging endeavor for any new drug. However, when your molecule exhibits poor bioavailability, there’s an even greater risk of costly delays and holdups.

View our video and download our case study!

INDiGO Case Study - Fast Tracked Drug Development Despite Being a BCS Class IV Drug