The Landscape
Post-Brexit, UK pharmaceutical manufacturers operate under MHRA regulations that have diverged from EU EMA requirements in meaningful ways. Clinical trial data management systems that were EU GMP compliant may now require re-validation for UK regulatory submissions. Engineering teams serving UK pharma need to track both frameworks simultaneously and design systems that satisfy both — not just the one the client mentions first.
The incumbents ship AI wrappers. We ship AI systems built for your regulatory environment — purpose-built, production-ready, and compliant from architecture through deployment.
Our Approach
Compliance Coverage
Every system we deploy for Pharmaceuticals & Life Sciences in United Kingdom is FDA 21 CFR Part 11-compliant from architecture through deployment. FDA 21 CFR Part 11- and -HIPAA compliance is enforced automatically at every commit — not assessed after the fact.
Engagement Scope
Duration: 8–16 weeks
A focused team of 10–30 engineers deployed against a single Pharmaceuticals & Life Sciences platform in United Kingdom. FDA 21 CFR Part 11 + HIPAA-compliant architecture from day one. Fixed price, fixed output, no discovery phase.
Duration: 3–9 months
40–100 engineers running parallel workstreams across a Pharmaceuticals & Life Sciences transformation in United Kingdom. Multi-system compliance governance, integrated delivery management, and FDA 21 CFR Part 11 + HIPAA certification maintained across the entire program.
Duration: 6–18 months
100–250+ engineers owning the complete technology infrastructure for a Healthcare organization in United Kingdom. Full FDA 21 CFR Part 11 + HIPAA compliance across every system, every integration, every deployment — from the first commit to the final sign-off.