Find it hard to innovate in the strictly regulated environment of drug development?

You’re not alone.

Problem: Recently, a client company faced a competitive threat to their leading product. The FDA issued new manufacturing guidelines that would have taken three years to implement, while their competition had already complied. The PD (process development) team proposed an innovative method that would cut two years out of implementation and save $10 million. The problem was that their executive team said it was too risky to recommend to the FDA.

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