Blockchain Adds a Trusted Data Layer in Pharma Manufacturing
Blockchain in pharma manufacturing could strengthen traceability, data integrity, and supply-chain visibility. Pharmatica examines the evidence and barriers.
One Global CMC Dossier? Digital Regulatory Submissions
Discover how digital CMC regulatory submissions, cloud collaboration, and AI accelerate the modernisation of manufacturing approvals and global pharma operations.
Why CMC Strategy Defines Cell and Gene Therapy Success
Cell and gene therapy CMC strategies, quality systems, and manufacturing innovation are critical to advanced therapy development and determine scalability.
How AI Is Opening New Opportunities in Fertility Care for Pharma
"If I had to get great minds in a room, I'd be looking at it from a tech perspective. How can we take all this knowledge, apply it to policies that can be easily distributed?” Clara Toombs, Fertilia AI.
MHRA Clarifies Licensing for Microbiome-Based Medicines
The MHRA has set out its position on microbiome-based medicinal products, confirming that a clear UK licensing route already exists for these therapies.
What the First FDA AI Warning Letter Means for Pharma
The FDA’s first AI warning letter shows Purolea Cosmetics Lab used AI to draft CGMP documents unchecked. Here’s what pharma manufacturers must learn now.