Meranda Parascandola

Analytical method validation activities really start long before the first validation study test is run—it begins within  the broader Chemistry, Manufacturing, and Controls (CMC) framework, where analytical activities are central to product quality assurance.. CMC requirements define how a drug is made, setting strict parameters that carry through formulation manufacturing, […]

Strong, phase-appropriate analytical methods help drive every stage of drug development—from early discovery to regulatory approval. These methods confirm a product’s identity, potency, purity, and safety, giving formulators, manufacturers and regulators the data they need to evaluate quality and gain product and process knowledge. For development teams, building and refining […]

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 […]