Find the gap. Fix the gap. Prove you fixed it.
AI-powered regulatory compliance from detection through resolution — gap analysis, CAPA creation, task assignment, closed-loop verification, and Part 11 audit trails across the entire drug lifecycle.
Clinplex AI is a complete regulatory compliance platform — not just a gap finder. From detection (AI-powered gap analysis against FDA, ICH, EMA, and global frameworks) through resolution (automated CAPA creation, task assignment, due dates, escalation workflows) to verification (closed-loop re-scanning, compliance trending, and 21 CFR Part 11 audit trails). Upload documents or integrate with Veeva Vault, MasterControl, TrackWise, and SAP QM. Every gap gets a path to closure.
One platform. Every phase.
From molecule to market to monitoring.
Most compliance tools cover one domain. Clinplex spans the entire regulatory landscape — and manages every gap from detection through verified closure.
Discovery & Preclinical
GLP compliance (21 CFR 58), research protocol documentation, data integrity controls, IND-enabling study readiness. Gap detection through CAPA closure.
Clinical Trials
GCP compliance (ICH E6), IND/CTA submissions, clinical site documentation, DSMB reporting, investigator brochure adequacy. Task routing to clinical ops.
Manufacturing & Quality
GMP compliance (21 CFR 210/211/820), batch records, deviations, CAPAs, process validation, environmental monitoring. Closed-loop verification on every fix.
Regulatory Submissions
eCTD Modules 1–5, NDA/BLA/ANDA assembly, CMC documentation, clinical summaries, submission readiness scoring. Remediation tracked to filing.
Post-Market & PV
Pharmacovigilance signal detection, PSUR/PBRER compliance, adverse event investigation, risk management plan evaluation. CAPA workflow with audit trail.
Detection. Resolution. Verification.
The complete compliance loop.
Upload a document or connect your systems. Clinplex doesn't just find problems — it creates the workflow to fix them and proves they're fixed.
Your way in
Upload any regulatory document — SOPs, batch records, clinical protocols, eCTD modules, PV reports — in PDF, Word, or Excel. Or connect to Veeva Vault, MasterControl, TrackWise, SAP QM, and CTMS for continuous monitoring.
AI gap analysis
Every record evaluated against 150+ regulatory frameworks — FDA CFRs, ICH guidelines, EU GMP, EMA requirements, eCTD specifications. Exact citations. Severity scoring. Cross-domain pattern detection.
Automated CAPAs
Every critical and major gap automatically generates a CAPA record with regulatory context, root cause classification, and specific remediation guidance. No manual translation from report to action.
Task ownership
CAPAs assigned to responsible individuals with due dates, priority levels, and escalation rules. Role-based routing ensures the right person owns each remediation — quality, regulatory, clinical, or PV.
Closed-loop re-scan
Remediated documents re-scanned against the same regulatory framework that flagged the original gap. Verification is automated — not dependent on someone remembering to check.
Part 11 audit trail
Every action — detection, assignment, escalation, remediation, verification, closure — timestamped with user attribution. Inspection-ready documentation generated automatically.
From detection to resolution.
Nothing falls through.
Every gap gets a CAPA. Every CAPA gets an owner. Every fix gets verified. Every action gets an audit trail.
Gap Detected
AI identifies regulatory deficiency with exact citation and severity
CAPA Created
Corrective action auto-generated with remediation guidance
Owner Assigned
Task routed to responsible person with due date and SLA
Escalation Rules
Overdue tasks auto-escalate through management chain
Re-Scan Verified
Remediated document re-analyzed against original requirement
Audit Trail Sealed
Full chain of custody — Part 11 compliant, inspection-ready
This is what separates a compliance platform from a gap finder. Detection without resolution is a report. Detection with closed-loop resolution, verification, and audit trails is a compliance system.
Deep intelligence in
every domain that matters.
Each domain gets the full loop — gap analysis, CAPA creation, task assignment, closed-loop verification, and audit trail.
Discovery & Preclinical
GLP protocol compliance, IND-enabling study documentation, research data integrity under 21 CFR Part 11, toxicology study report completeness.
Clinical Trials & GCP
Clinical protocol compliance, informed consent adequacy, investigator brochure completeness, IND/CTA submission readiness, ICH E6(R2) adherence.
Manufacturing & GMP
Batch record review, deviation investigation adequacy, CAPA root cause rigor, process validation documentation, environmental monitoring.
Regulatory Submissions
eCTD Module completeness scoring, CMC section gap analysis, clinical overview adequacy, Module 2.5/2.7 cross-referencing, NDA/BLA/ANDA verification.
Pharmacovigilance
Adverse event investigation compliance, PSUR/PBRER documentation adequacy, signal detection analysis, risk management plan evaluation, REMS monitoring.
Cross-Domain Intelligence
Connects signals across all five domains — manufacturing deviations that impact submissions, PV signals that require labeling updates, clinical findings that change GMP requirements.
What changes when gaps
actually get closed.
Detection without resolution is a report sitting in someone's inbox. The full loop — detect, assign, fix, verify, document — is what changes compliance posture.
Faster gap detection
Issues surfaced in hours, not the 3–6 months periodic audits take.
Faster gap resolution
Automated CAPA creation and task routing eliminates weeks between finding a problem and assigning someone to fix it.
Audit trail coverage
Every detection, assignment, escalation, remediation, and verification — timestamped and Part 11 compliant.
Annual cost avoidance
Reduced consulting, fewer CRLs, prevented warning letters and submission delays.
Per document analysis
Upload any regulatory document and get a complete gap report — with CAPA workflow — in seconds.
Gaps without owners
Every critical and major gap gets a CAPA, an owner, a due date, and an escalation path. Nothing sits unassigned.
From first IND filing
to global PV operations.
Pre-clinical & emerging biotech
Building your regulatory infrastructure from scratch? Upload your GLP protocols and IND-enabling studies. Know exactly where gaps exist — and get a CAPA workflow to close them before your first FDA interaction.
Clinical-stage companies
Navigating IND submissions and GCP compliance? Clinplex evaluates your clinical documentation against ICH E6 and FDA requirements — then creates task-assigned CAPAs with due dates for every deficiency.
Commercial pharma & CDMOs
Managing GMP manufacturing, regulatory submissions, and post-market obligations across multiple sites. Continuous monitoring with automated CAPA routing, closed-loop verification, and compliance trending your QMS can't do.
Regulatory affairs & PV teams
Preparing NDA/BLA submissions, managing eCTD modules, running pharmacovigilance programs. Submission readiness scoring, PV compliance monitoring, and full remediation workflow with Part 11 audit trails.
Regulatory intelligence,
explained.
AI-Powered Regulatory Gap Analysis
How AI replaces manual audits with continuous detection, automated CAPAs, and closed-loop verification.
Read →FDA 483 Prevention with AI Pattern Detection
The most common 483 citations and how AI identifies patterns — then creates CAPAs to prevent them.
Read →AI + Veeva, MasterControl & TrackWise
How regulatory intelligence integrates with enterprise systems for continuous monitoring and resolution management.
Read →Pharmaceutical RegTech 2025
Where full-loop regulatory compliance fits in the pharma technology stack.
Read →Start with one document.
See the full compliance loop.
Upload a clinical protocol, SOP, eCTD module, or PV report. Get a gap analysis with CAPA workflow — detection through verified resolution — in seconds.