Reprosia brings AI-driven rigor to pharmaceutical research — from first analysis to regulatory submission. Built on open-source foundations. Designed for compliance-first teams.
Most clinical analyses cannot be reproduced. Regulatory submissions fail. Decisions are made on results that were never designed to be verified. Reprosia exists to fix this.
Regulatory agencies are tightening requirements. FDA and EMA now expect documented, auditable, reproducible analyses as standard — not exception.
Most teams rely on ad-hoc R scripts, undocumented environments, and manual validation processes that break at submission time. The cost is measured in delayed approvals, failed audits, and lost competitive advantage.
Reprosia automates the infrastructure of rigor — so your team can focus on the science, not the paperwork.
Not a reporting tool. The infrastructure layer that makes pharmaceutical analyses trustworthy from day one. Explore the platform →
AI-assisted IQ/OQ/PQ validation of your R environment. Continuous audit trails compliant with 21 CFR Part 11. Every function call documented automatically.
Locked package versions, containerised execution, drift detection. Your results today match your results at submission — regardless of environment or time.
Regulatory-ready outputs for FDA and EMA. CDISC-compatible structures, ICH E9(R1) estimand documentation, eCTD-ready packages.
From Phase I to NDA. From clinical biostatistics to SAS migration. See all use cases →
Reproducible SAPs, locked environments at database freeze, automated audit trails for DSMB and regulatory review. From Phase I to NDA/BLA.
Learn more →Validate your R environment to agency standards. Generate IQ/OQ/PQ documentation automatically. Never fail a submission audit again.
Learn more →Consistent validation across multiple sponsor environments. Deliver reproducible analyses regardless of client infrastructure.
Learn more →Migrate from SAS to R without losing compliance posture. Automated equivalence testing and parallel validation.
Learn more →Reprosia is in private early access. We are working with a small number of pharma and biotech teams to shape the platform.
Or reach us at ndoh@reprosia.com