A single-registration pathway would allow distributed networks to add, remove, or relocate units with less administrative complexity while maintaining centralized quality oversight and improved FDA ...
Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry. This week, regulators, dealmakers, and manufacturers converged on the same ...
PharmTech spoke with Jamie Evans, manager of analytical method development and validation, and Joe Cobb, CPIP, manager of formulations, both with Lonza Capsugel, about best practices for ...
Teva gains exclusive commercialization rights for IV and SC ocrelizumab biosimilar formulations across the US, Europe, Brazil, Canada, Australia, New Zealand, Israel, and Turkey, pending approvals.
Operational margins increasingly track efficiency, making manual steps and disconnected systems direct drivers of cost, delays, and variable quality at higher sample volumes. Automated, standardized ...
Tim Stroud is Solutions Consultant Team Leader at Cenevo. He is an experienced life sciences professional with more than 20 years in the pharmaceutical drug discovery industry. Prior to joining Cenevo ...
Patient nonadherence rates of 30%–50% are linked to dosing complexity and poor acceptability, motivating patient-centered formulation strategies, especially for pediatrics and older adults. A ...
Angela Strzelecki, PhD, is senior vice president of the Roquette Group and CEO of Roquette’s Health & Pharma Solutions Business Unit ...
USP standards enhance reliability by reducing process variability, improving technology transfer, and supporting regulatory alignment, particularly relevant for generics and multi-site manufacturing ...
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