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, ...

Patrik Florencio | Authors | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.

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 ...

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

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 ...