Drug developed halted by formulation challenges, CMC issues, or pharmacokinetic deficiencies can feel like the program has slid back down to the bottom of a mountain. Our belief is the best solution is to examine these challenges with a fresh set of eyes, not bogged down by what has been attempted before.

We work with clients to reformulate a drug to solve problems encountered during development or for abbreviated regulatory pathways such as the 505(b)(2) or sNDA pathways