AI-Native Regulatory Affairs

Your Virtual AI
Regulatory Affairs
Agency

RegAgents is a project-centric multi-agent workspace purpose-built for pharmaceutical regulatory and quality teams — from question to traceable, evidence-backed answer in minutes, not weeks.

Book a Demo See how it works
$8.9B
Global Pharma RA
Market (2025)
15%
RMS Segment
CAGR to 2032
200–400 hr
Specialist time per
submission cycle
40–60%
Cycle time reduction
with RegAgents
The Problem
4–8 wk
Audit Response Time
GMP inspector queries require weeks of manual evidence gathering across scattered files, emails, and institutional memory.
35%
Time Searching
RA professionals spend over a third of their working hours searching for information — not applying their expertise.
$150–250K
Knowledge at Risk
Replacement cost when a senior RA expert leaves. Institutional knowledge walks out the door with every departure.

Regulatory complexity is increasing faster than teams can scale. Global harmonization initiatives add layers of cross-referencing, while submission volumes grow 8–12% annually. The talent pipeline is shrinking. The result is a structural gap that only intelligent automation can close.

The Product
01
Faster Conclusions
Multi-agent reasoning orchestrates RA, QA, CMC, and Clinical experts in parallel on your actual project data — delivering synthesized answers in minutes, not days.
02
Traceable Evidence
Every AI-generated insight links back to its source document with page-level citations. Human reviewers accept, reject, or annotate each piece of evidence.
03
Controlled Collaboration
Project boundaries enforce data isolation. Role-based access, append-only audit logs, and RegDoc version control ensure every action is recorded and attributable.
Workflow — From Question to Auditable Answer
Ask
User poses a question
In a project-scoped thread, with full context isolation
Route
Orchestrator assigns agents
Intent identified, domain specialists activated
Retrieve
Agents search docs
Project knowledge bases + professional references
Create
Structured response
Multi-agent synthesis with source citations
Review
Human validates
Accept, reject, or annotate each evidence item
Remember
Context persists
Compressed into project memory for future queries
Built For
Pharma / Biotech
Submission Preparation
Dossier assembly across RA, QA, CMC, Clinical
Pain
200–400 specialist-hours per submission cycle. Cross-functional alignment is manual, slow, and error-prone.
Value
Multi-agent parallel review cuts cycle time 40–60%
CRO
Multi-Client Project Management
10–50 parallel client projects with strict isolation
Pain
Must maintain strict client data isolation while running projects in parallel. Any data leak is a contractual failure.
Value
Project-as-boundary + audit trail satisfies client SLAs and regulatory audits
CDMO
Audit Response
GMP inspector queries and site audits
Pain
GMP inspector queries require 4–8 weeks of manual evidence gathering across manufacturing records.
Value
AI-assisted evidence retrieval + traceable citations reduce response to 1–2 weeks
RegDoc
Git solved versioning for code. RegDoc solves it for compliance documents.
Every doc-commit records both author and approver — a dual-signature model that maps directly to GxP requirements. Content-addressable storage ensures document integrity: any tampering is cryptographically detectable.
Git Concept RegDoc Equivalent Compliance Value
commit doc-commit Who changed what, when, why — with approver. Dual-signature model for GxP.
branch doc-branch Parallel versions: submission / remediation / regional adaptation
pull request review-request Formal approval workflow with full audit trail
git log doc-log Append-only, immutable change history for 21 CFR Part 11 compliance
push / pull regdoc push / pull App & Web Hub sync for distributed teams
Strategic Position
AI CAPABILITY → COMPLIANCE DEPTH ↑ Veeva IQVIA Master ChatGPT Reg Agents UNCONTESTED
Occupying the Upper-Right Quadrant No Incumbent Owns
Traditional RIM vendors dominate compliance but their AI features are nascent. General-purpose LLMs offer powerful reasoning but zero compliance infrastructure. RegAgents is designed from day one to be both AI-native and compliance-deep.
Veeva / IQVIA
Fails on AI capability — compliance-strong but reasoning-shallow
ChatGPT / Claude
Fails on compliance — zero traceability, no project isolation
RegAgents
AI-native reasoning + GxP-grade audit trail + local-first privacy
Get in Touch
Let's build the future of pharmaceutical regulatory affairs.
Email
ywu@ywustudio.com
For demos, pilots, and investment conversations
Schedule
Book on Calendly
30-min intro call or product walkthrough
Founder
Yifan Wu — wuyifan.site
Background in Pharma Sciences, VC, and AI
Tweaks
Visual Theme
Options