Life sciences organisations operate under the strictest quality and regulatory requirements of any industry. We build validated software systems for pharma companies, CROs, and medical device manufacturers that meet FDA and EMA standards.
Understanding the unique pressures and constraints of your industry lets us build solutions that actually fit, rather than generic tools that need to be worked around.
FDA 21 CFR Part 11, EU Annex 11, and GxP requirements for computer system validation add significant cost and time to every software deployment.
Managing data from multiple sites, multiple patient populations, and complex protocols across EDC, CTMS, and safety systems requires sophisticated integration.
LIMS, ELN, and instrument data need to be integrated, traceable, and auditable. Paper-based lab workflows are slow and error-prone.
Track-and-trace requirements for pharmaceutical serialisation under DSCSA and EU FMD require end-to-end visibility across complex distribution networks.
From strategy to delivery, every engagement is shaped around the specific workflows, regulations, and user expectations of your industry.
GxP-validated LIMS with sample tracking, test management, instrument integration, and electronic lab notebooks.
CTMS platforms for site management, patient recruitment, study progress tracking, and regulatory submission support.
Adverse event collection, case processing, regulatory reporting, and signal detection platforms for drug safety teams.
Pharma serialisation platforms meeting DSCSA and EU FMD requirements, integrating with packaging lines and distribution networks.
Validated QMS for document control, deviation management, CAPA, change control, and audit management with electronic signatures.
Data integration from EDC, safety, and CTMS systems for real-time trial oversight, site performance, and regulatory intelligence.
We do not hand your project to a generalist team that will spend the first month learning your industry. Our teams come with domain context, existing integration patterns, and a track record in your specific space.
Tell us about your project and we will come back with an honest assessment, relevant examples from your industry, and a realistic delivery plan.
