Quality Assurance & cGMP

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

What the First FDA AI Warning Letter Means for Pharma

Pharmatica image of a quality professional reviewing AI-assisted CGMP documentation in a pharmaceutical manufacturing environment.

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.

Nicole Dale

ICH M12 Drug Interaction Studies: EMA Targets the Gut Gap

Pharmatica image of a bright pharmaceutical laboratory bench with glass vials and a soft red ribbon, representing ICH M12 drug interaction studies and the EMA gastrointestinal guideline.

The EMA’s draft guideline extends ICH M12 drug interaction studies to the gut. See what it asks on food effect, gastric pH, and excipients, and how to respond.

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.

Nicole Dale

Cold Chain Optimisation by Rethinking Pharma Logistics

Pharmatica image of pharmaceutical cold chain optimisation using temperature-controlled logistics, monitoring, and supply chain technology.

See how cold chain optimisation can reduce pharmaceutical logistics costs, emissions, and product risk by modelling uncertainty across storage and distribution.