Commercialisation & Medical Affairs

Nicole Dale

FDA PreCheck Pilot Program to Build Manufacturing Readiness

Pharmatica image of regulatory inspectors reviewing digital drug manufacturing systems in a pharmaceutical production facility, illustrating the FDA PreCheck Pilot Program, manufacturing readiness, U.S. domestic drug manufacturing, and advanced pharmaceutical manufacturing.

The FDA PreCheck Pilot Program aims to strengthen U.S. domestic drug manufacturing through regulatory engagement, manufacturing readiness, and advanced production.

Nicole Dale

Modular Pharma Factories: The Next Step for Continuous Manufacturing?

Pharmatica image showing modular pharmaceutical manufacturing using continuous pharmaceutical manufacturing processes, interconnected production modules, and Process Analytical Technology to improve flexible drug manufacturing.

Discover how modular pharmaceutical manufacturing and continuous production could improve flexibility, resilience, and efficiency across modern pharmaceutical operations.

Nicole Dale

Blockchain Adds a Trusted Data Layer in Pharma Manufacturing

Pharmatica image of a realistic pharmaceutical manufacturing environment featuring interconnected stainless‑steel bioreactors and tanks linked by glowing yellow blockchain data pathways and hexagonal nodes with padlock icons, symbolising secure data integrity, traceability, and AI‑driven innovation in pharma manufacturing.

Blockchain in pharma manufacturing could strengthen traceability, data integrity, and supply-chain visibility. Pharmatica examines the evidence and barriers.

Nicole Dale

One Global CMC Dossier? Digital Regulatory Submissions

Pharmatica photo‑realistic representation of CMC regulatory submissions showing global data networks, secure digital dossier exchange, and pharmaceutical manufacturing integration — document binders, connected globe, red padlock cybersecurity icon, and industrial equipment with red‑capped vials illustrate digital CMC submissions, regulatory reliance, and manufacturing quality.

Discover how digital CMC regulatory submissions, cloud collaboration, and AI accelerate the modernisation of manufacturing approvals and global pharma operations.

Nicole Dale

Why CMC Strategy Defines Cell and Gene Therapy Success

Pharmatica image of a modern cell and gene therapy manufacturing facility supporting advanced CMC strategy through GMP production, digital process monitoring, pharmaceutical quality systems, and bioprocess innovation.

Cell and gene therapy CMC strategies, quality systems, and manufacturing innovation are critical to advanced therapy development and determine scalability.

Shubhangi Dua

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.