Effective regulatory responses are concise and evidence-based, explicitly connecting observations to root cause, corrective ...

The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits ...

As cell and gene therapies move from bespoke academic protocols into commercial-scale manufacturing, the raw materials underpinning them are emerging as one of the most consequent ...

FDA will review discrete IND modules during pre-IND rather than waiting for a full submission, with the goal of de-risking ...

As part of PharmTech’s coverage of CPHI Milan, Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, ...

Risk management in medical devices carries 2 identities. ISO 14971 defines a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk, and monit ...

Timothy Bassler, SVP of Quality Operations at PCI Pharma Services, presented "Driving Quality Culture to Manage Risk," using a ...

Since July 2026, the European Union (EU) has shifted its focus from legislative reforms to practical applications, prioritizing supply-chain resilience, preventing medicine shortages, streamlining ...

Keshav Bhutada, chief executive officer of Shilpa CDMO, said the company has long been recognized among existing partners for its capabilities with challenging molecules such as high-potency APIs ...

Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains that developing a molecule requires a holistic view of its chemical, physical, and biological properties.

Christy Owings, vice president and general manager of the Americas business unit, Thermo Fisher Scientific, connected with ...