The Landscape
Gulf pharmaceutical manufacturers — particularly those serving SFDA in Saudi Arabia and MOHAP in the UAE — are building or expanding GMP-compliant manufacturing execution systems on accelerated timelines driven by Vision 2030 and national pharmaceutical self-sufficiency goals. The regulatory frameworks are stringent and evolving. Our teams deploy with Gulf regulatory requirements already mapped to the system architecture.
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 UAE & Gulf 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 UAE & Gulf. 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 UAE & Gulf. 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 UAE & Gulf. Full FDA 21 CFR Part 11 + HIPAA compliance across every system, every integration, every deployment — from the first commit to the final sign-off.