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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.

Nicole Dale

FDA vs EMA Drug Labelling for Global Medical Safety

Pharmatica image for U.S. and European pharmaceutical regulation represented by medicine packaging, printed product information, and digital labelling on a smartphone.

We explain the FDA vs EMA drug labelling requirements, regional safety differences, pharmacovigilance updates, and the role of harmonisation in medicine safety.

Nicole Dale

Making Flexibility Work with Adaptive Clinical Trials

Pharmatica image showing two clinical researchers in white laboratory coats reviewing trial data on a digital tablet in a modern pharmaceutical research environment. The background shows laboratory equipment and translucent scientific graphics, symbolising adaptive clinical trial design, evidence‑driven decision‑making, and digital data integration in clinical development.

Adaptive clinical trials can improve efficiency, reduce patient burden, and support faster development through structured, evidence-based flexibility.