For decades, the power and potential of outsourcing has been viewed as a way for pharmaceutical companies to gain access to specialized domain expertise across geographic regions and achieve cost savings amidst a highly complex and diverse regulatory environment.
In the face of dwindling drug pipelines, complex regulations and block-busters crossing their patent exclusivity, mature products offer a revenue stream for companies to sustain their bottom lines in a hyper-competitive global market.
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.