Fast-tracked Development Despite being a BCS Class IV Drug

Poor Bioavailability, An Even Greater Risk of Costly Delays & 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.

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