FDA will review discrete IND modules during pre-IND rather than waiting for a full submission, with the goal of de-risking ...
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 ...
As part of PharmTech’s coverage of CPHI Milan, Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, ...
Sanofi and Cheplapharm have announced plans for a strategic partnership that would transfer 20 mature medicines and three ...
High-concentration biologics are pushing the limits of what can be formulated, filled, and delivered as a low-volume ...
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains that developing a molecule requires a ...
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 ...
Christy Owings, vice president and general manager of the Americas business unit, Thermo Fisher Scientific, connected with ...
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 ...
Christy Owings, vice president and general manager of the Americas business unit at Thermo Fisher Scientific, discusses with ...
On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
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