Regulatory & IP

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.

Nicole Dale

MHRA Clarifies Licensing for Microbiome-Based Medicines

Pharmatica image of abstract red microbial imagery on a soft white background, representing microbiome-based medicinal product UK regulation.

The MHRA has set out its position on microbiome-based medicinal products, confirming that a clear UK licensing route already exists for these therapies.

Nicole Dale

Genomic Governance Ensures Equity at the Core of Drug Discovery

Scientists analysing diverse genomic datasets to support genomic equity, AI-driven drug discovery, and precision medicine in pharmaceutical research.

Discover why genomic equity is essential for reliable AI-driven drug discovery, precision medicine, and building more representative pharmaceutical innovation.

Nicole Dale

Next-Generation Sequencing for Cell Line Development in Biologics Manufacturing

Laboratory illustrating next-generation sequencing cell line development for biologics manufacturing, highlighting DNA analysis, genomic characterisation, bioprocess development, Quality by Design, and pharmaceutical manufacturing innovation.

Discover how next-generation sequencing in cell line development is improving biologics manufacturing, quality control, and regulatory confidence.