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.
Compliance bolted on after the fact costs 3x what compliance built in from the start costs. By the time the audit firm finds the gap, the architecture is already locked.
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.