Our facility in Bridgeton, MO, delivers Annex 1 compliance with every line. Along with our other facilities in the St. Louis area, this site makes us one of only a few CDMOs capable of servicing sterile fill, device manufacture, and final assembly in one geographic location. This saves you time and money while reducing your carbon footprint.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.