Transform promising molecules into approved therapies faster. Our platform cuts document-intensive tasks by up to 70%, shaving weeks off pre-pivotal and pivotal timelines.
Unify Your Workflows
Connect process development, quality assurance, and regulatory compliance in a single environment. No more fragmented tools, disconnected data, or duplicated effort across teams.
Deliver Better Outcomes
Bring life-saving medicines to market more quickly, reduce costs, and maintain the highest standards of compliance, with every AI output reviewed and approved by your SMEs.
FDA 21 CFR Part 11 Ready
EU GMP Annex 11
TLS 1.3 Encryption
Single-Tenant Architecture
Human-in-the-Loop Agents
Immutable Audit Trails
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Workspace
Risk Assessment
Workflows 3
Documents
Analytics
Supplier Mgmt
Root Cause
Agents
CMC Agent ●
Reg Affairs Agent
QA Agent
⚙
IND Amendment: Module 3.2.S
ICH Q11 · 6 parallel agent tracks · SME gate required at each checkpoint
Add purified water (30–35 mL/kg) to the blend. Operate at impeller speed 250 rpm for 8 minutes. Monitor endpoint by power consumption.
Batch yield target: 97.0–100.5%.
Rev.3: AI-Proposed · awaiting SME sign-off
4.3 Granulation Step
Add purified water (28–33 mL/kg) to the blend. Operate at impeller speed 220 rpm for 10 minutes. Monitor endpoint by torque measurement (VM-044).
Batch yield target: 96.5–100.0%.
❆ Aligned with pivotal batch PB-2024-12 · ICH Q11 §3.2.S.2 · ref. BR-2024-031
Top Changes: Agent Rationale
Impeller speed 250 → 220 rpm0.96 · ref PB-2024-12
Endpoint: power → torque (VM-044)0.94 · ref AM-2023-09
Mix time: 8 min → 10 min0.91 · ref DOE-2024-07
✓ Approve & route for e-sig
✕ Reject selected
⏎ Escalate to senior SME
🔍 All 11 changes
📊
Pipeline Readiness Dashboard
Program MX-401 · Phase II→III · Predictive AI · Live agent telemetry
1 blocker · on-track overall
94%
CMC Readiness
37
Docs AI-Drafted
3
Pending SME Review
⚠ Blocking §S.7 draft
−68%
Time vs. Manual
≈ 6.2 wks saved
Phase Completion + Predicted Close
Process Development100%
Analytical Methods100%
Stability Program81%
Predicted complete: Apr 28
Regulatory Package67%
Predicted complete: May 14 · on track
Agent Telemetry: Last 24h
●CMC Agent drafted §3.2.S.2.6 · routed to Dr. Patel · conf 0.97
●QA Agent proposed 4 change controls · all pending human review
●Reg Agent reconciled 22 CTD refs · 2 flagged for SME · conf 0.89
⚠Blocker T=12M stability pending; §3.2.S.7 gated until results arrive
CMC
QA
Reg
Risk
⚠
Risk Assessment Agent
ICH Q9 / FMEA-based scoring · AI confidence-weighted · Human-in-the-loop
2 critical · 5 medium · 18 cleared
ICH Q9 Risk Matrix
LowSeverity →High
2
Critical (RPN ≥ 75)
5
Medium (RPN 40-74)
94%
Compliance Score
0.91
AI Confidence
⚠ CRITICAL: Stability Data Gap
RPN 84Module 3.2.S.7
T=18M stability time-point unavailable. Predictive model estimates 78% probability of IND delay (6-8 weeks) without accelerated study. Agent recommends parallel accelerated study initiation.
⚡ Escalate to SME
View mitigations
Detectability: 3 · Severity: 4 · Occurrence: 7
⚠ CRITICAL: Supplier GMP Expiry
RPN 78RM-07 · 18 days
GMP certificate expires in 18 days. Audit overdue 12 days. Cross-checked against 3 alternative qualified suppliers. Supplier E can cover interim supply within 5 business days pending SME approval.
Qual score 45/100 · Incomplete; 4 docs outstanding
⚠ Supplier D: RM-07Action Required
GMP cert expires in 18 days · Audit overdue
⚠ Qual score 22/100 · Emergency audit required
Agent Recommendation: Awaiting SME Approval
Initiate emergency audit for Supplier D (RM-07). Agent has pre-identified Supplier E as qualified interim source; can fulfil next PO within 5 business days. Procurement hold recommended until re-cert confirmed. No action executes without SME sign-off.
PA-1Add in-process speed verification every 2 min · update SOP-MFG-034
✓ Approve CAPA & close deviation
✎ Edit proposed actions
📤 Route to QA for e-signature
📋 View 3 analogous events
AI
RCA Agent · just now
Root cause confirmed: mill speed sensor drift (+47d overdue PM). CAPA actions drafted above, ready for your approval before QA routing.
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Core capabilities
Everything your team needs in one platform
Workflow Orchestration
Automate and manage complex, multi-step processes across teams and departments, with your team in control at every critical checkpoint.
Knowledge Management
Centralize your data and insights to build a single source of truth: searchable, auditable, and accessible to the right people at the right time.
Human-in-the-Loop AI Agents
Specialized agents that assist with complex tasks, from CMC documentation to regulatory submissions, with your SMEs validating every critical output before it becomes a record.
Document Harmonization
Ensure consistency and quality across all regulatory and clinical documents, with tracked changes reviewed and approved by your team before any revision is finalized.
Data Integration
Connect diverse data sources including manufacturing records, analytical data, and stability studies, to give your team a holistic, real-time view of your entire development pipeline.
Security & Compliance
Single-tenant architecture, TLS 1.3 encryption, MFA, immutable audit logs, and full alignment with FDA 21 CFR Part 11 and EU GMP Annex 11.
Contact us today.
See how validated AI agents can save your team 30% of their work week, across CMC, quality, and regulatory functions.