Pharmaceutical data science has a reproducibility problem. Reprosia exists to build the infrastructure layer that makes regulated analyses trustworthy by design.
Reprosia started with a clear observation: reproducibility in clinical analyses is harder than it should be. R environments go undocumented, package versions drift, and the steps between raw data and submission output are rarely captured in a way that can be independently verified.
This is a solvable problem. The tools exist in open-source R. The regulatory requirements are well-understood. A platform that connected them — making compliance a natural outcome of the workflow rather than a separate effort — did not yet exist in the R ecosystem.
We built Reprosia to be that platform. AI-native, built on open-source foundations, designed for teams operating under regulatory scrutiny: pharma, biotech, and CRO statisticians working under FDA and EMA oversight.
We are not a regulatory consultancy that happens to use software. We are a technology company that deeply understands regulation. The distinction matters: our goal is to encode regulatory expertise into software that scales — not to bill consulting hours indefinitely.
The open-source foundation — bayprior, reproducr, regulog, lineager, and estimandr — is our commitment to the community. These packages solve real problems for individual statisticians and teams. Reprosia is the platform that makes those solutions work at enterprise scale, with the AI audit layer, environment management, and submission tooling that regulated environments require.
We are based in Brussels, Belgium, based in Brussels, Belgium. We work with pharma and biotech teams across Europe and globally. EU data residency is built in, not bolted on.
This is early days. We are working with a small number of teams in private early access. If reproducibility is a problem you are trying to solve, we want to talk to you.
The reproducibility problem belongs to the community. Our packages are open-source, openly developed, and will remain so. The platform adds enterprise capabilities — it does not hide the science behind a paywall.
We don't build workarounds for regulatory requirements. We build tools that make compliance easier to achieve — and harder to accidentally skip. The goal is a world where doing the right thing is also the easiest thing.
Clinical statisticians should be thinking about their estimand strategy, not debugging R package dependencies. Reprosia handles the infrastructure so people can focus on the science.
In regulated environments, every claim must be verifiable. We hold ourselves to the same standard: our methods are openly documented, our outputs are traceable, and our claims are verifiable.
We use AI to make compliance more thorough, not less rigorous. AI is the audit engine — it catches what humans miss, at a scale no manual process can match. It does not replace regulatory judgment; it extends it.
Biostatistician and R developer based in Brussels, Belgium. Before building Reprosia, Ndoh spent years working on clinical trial analyses in regulated environments, developing deep familiarity with the reproducibility and compliance challenges that statistical teams face at submission time.
That experience shaped a conviction: the tools to address these challenges exist in open-source R, but bringing them together into a cohesive, enterprise-ready platform required deliberate design. ReproStats started as that toolkit — five openly developed R packages covering Bayesian prior methodology, reproducibility, audit logging, data provenance, and estimand specification. Reprosia is the platform layer that makes them enterprise-grade.
Ndoh's expertise spans ICH E9(R1) estimand methodology, Bayesian methods for clinical trials, 21 CFR Part 11 compliance for R environments, and CDISC data standards for regulatory submissions.
Reprosia is built on five openly developed R packages — bayprior, reproducr, regulog, lineager, and estimandr. Two are live on CRAN today; the remaining three are in active development. The platform adds the AI-assisted audit engine, environment management, and regulatory submission tooling on top of a foundation that belongs to everyone.
Full documentation, install instructions, vignettes, and contribution guidelines live at reprostats.org.
Early access is limited. We work directly with every team to understand their environment and tailor the platform to their regulatory context.
Or email team@reprosia.com