Move science forward — without breaking compliance.
StewardIQ gives biopharma teams a single engine to plan initiatives, govern clinical and CMC data, and adopt change across R&D, QA, and regulatory — with evidence ready for any inspection.
What we govern
Built for the rhythms of drug development
From discovery through commercial, StewardIQ wraps your data lifecycle in stewardship that regulators recognize.
GxP & 21 CFR Part 11
Electronic records and signatures captured with audit-grade evidence across every initiative and dataset.
Clinical data lineage
Trace patient, study, and site data end-to-end — from EDC to submission — without manual reconciliation.
CMC & manufacturing
Govern batch, tech-transfer, and supply data with SOPs and stewardship workflows your QA team will trust.
Regulatory submissions
Standardize attributes, rules, and frameworks so eCTD assembly and health-authority responses move faster.
Pharmacovigilance
Adverse-event signal stewardship with controlled vocabularies, escalation paths, and full traceability.
AI you can defend
Generative AI accelerates SOPs, drafts, and analysis — every output linked to its source for inspection readiness.
Bring stewardship to your next submission.
See how biopharma teams use StewardIQ to standardize SOPs, accelerate trials, and stay inspection-ready.