Regulatory expectations keep expanding while timelines keep shrinking. The cost rarely comes from a shortage of expertise - it comes from expert judgement being spent on work that does not need it.
Pace Wisdom Solutions builds AI-native systems for organisations whose work is judged by the evidence it produces. We partner with device manufacturers, pharmaceutical companies and CDMOs, sponsors and CROs, and consumer health brands - across regulatory affairs, quality, clinical operations and pharmacovigilance.
Your experts own the science and the interpretation. We build the technology that lets theirjudgement reach everything it should and execute workflows faster - inside your validatedenvironment, with a named reviewer signing off.
Agentic AI for regulated workflows, knowledge platforms that connect information scattered across systems, and the data and cloud foundations beneath both. In practice that means agents that check file gaps, regulations readiness, assemble quality reviews, documentation intelligence, knowledge graphs etc.
No, and we do not sell that. Your regulatory team knows your products and your interpretations better than any vendor could. We build the technology that applies your rules across everything you hold, instead of the sample a person has time to read.
The same way you validate any system that touches regulated work, and we support that process. FDA's Computer Software Assurance guidance is risk-based - your team classifies the tool by intended use and process risk, then scales assurance activity accordingly. We provide documentation for your validation package rather than a certificate, because no such certificate exists for this category.
Three things are designed for exactly that. Every output points at the source record it came from, so a reviewer verifies rather than trusts. Anything the system is uncertain about is surfaced rather than closed silently. And a named reviewer approves before anything is final.
Those are systems of record: they store, route and version documents. We read across what is already in them and check it against the requirements that apply. Different job, and the two work together rather than competing.
That constraint is normal in this industry and we design around it rather than retrofitting. The right architecture depends on your infrastructure and security posture, so we bring your IT and security teams into the conversation early.
We start by assessing how the work runs today rather than demonstrating software, because every organisation's SOPs differ. Once scoped, the target is a first agent running in your validated environment within weeks rather than quarters.
From a scoped first agent through to a managed programme across multiple workflows. Most engagements begin with one high-burden workflow, so the approach is proven in your environment before it is extended.
Yes. We work with organisations in India and elsewhere that export into regulated markets - often the ones carrying the heaviest burden, since the same product has to satisfy several regimes at once, each wanting the same evidence in a different structure.
