The Landscape
TGA-regulated pharmaceutical systems in Australia carry electronic records requirements under the TGA's data integrity guidance that mirror FDA 21 CFR Part 11 in substance if not in citation. APRA's financial services frameworks further complicate systems that sit at the intersection of pharmaceutical manufacturing and health fund integration. We serve this intersection with engineering teams who know both regulatory regimes.
When the regulation changes, most engineering teams find out from legal — weeks after the fact. Our systems surface regulatory changes in real time and translate them into engineering requirements before the lawyers finish drafting the memo.
Our Approach
Compliance Coverage
Every system we deploy for Pharmaceuticals & Life Sciences in Oceania 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 Oceania. 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 Oceania. 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 Oceania. Full FDA 21 CFR Part 11 + HIPAA compliance across every system, every integration, every deployment — from the first commit to the final sign-off.