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End-to-end transparency is imperative in the pharmaceutical industry. Within drug substance development, transparency means having clear, comprehensive visibility at every stage, from initial process research through scale-up, validation, and manufacturing. It involves consistently documenting data, decisions, and changes, ensuring that nothing critical is lost in translation between development phases or […]

Delays in drug development often trace back to overlooked CMC challenges. These technical details—how a drug is made, quality controlled, and tested—shape the path from lab to patient. A strong candidate can stall when formulation or manufacturing plans fall short. Teams that invest early in strategic CMC planning avoid costly […]