Complete regulatory compliance. Detection to resolution.
From discovery through pharmacovigilance — whether you run a $50M enterprise stack or manage regulatory compliance from spreadsheets — Clinplex gives you continuous AI-powered gap detection, automated CAPA workflows, closed-loop verification, and Part 11 audit trails.
Finding gaps is the easy part. Fixing them — with accountability, verification, and audit trails — is where every compliance program breaks down. A gap report without a CAPA is a suggestion. A CAPA without an owner is a wish. An owner without a deadline and escalation path is a gamble.
The pharmaceutical industry manages regulatory compliance in silos — GLP teams, clinical operations, manufacturing quality, regulatory affairs, pharmacovigilance — each with their own systems, their own audits, their own blind spots. When they do find gaps, the path from detection to verified resolution runs through spreadsheets, email chains, and manual follow-up.
Clinplex was built to close both gaps: the intelligence gap (finding what's wrong) and the resolution gap (proving it's fixed). One platform that spans every phase of the drug lifecycle — from discovery through post-market surveillance — with automated CAPA creation, task assignment, escalation workflows, closed-loop verification, and 21 CFR Part 11 audit trails on every action.
One platform.
Two ways in.
Your regulatory infrastructure is unique. Clinplex meets you where you are — and delivers the full compliance loop either way.
Upload, analyze, resolve
No integration required. Upload any regulatory document and get severity-scored gap analysis with automated CAPA generation, task assignment, and closed-loop verification — all in one workflow.
- Pre-IND biotech building from scratch
- Clinical-stage companies preparing submissions
- CDMOs and contract research organizations
- Gap report → CAPA → assigned owner → verified fix
- Full Part 11 audit trail on every action
Connect, monitor, resolve
Already running enterprise systems? Clinplex connects directly, continuously monitors records, creates CAPAs from detected gaps, routes tasks to responsible owners, and tracks resolution to verified closure.
- Veeva Vault, MasterControl, TrackWise, SAP QM
- Clinical trial management systems (CTMS)
- Continuous gap detection → automated CAPA workflow
- Escalation rules, due dates, SLA tracking
- Cross-domain pattern detection and resolution
What makes this different.
Detection to resolution
Not just a gap finder. The complete loop: AI detection → CAPA creation → task assignment → escalation → closed-loop re-scan verification → Part 11 audit trail. Every gap gets a path to closure.
Full lifecycle intelligence
One platform covering GLP, GCP, GMP, regulatory submissions, and pharmacovigilance — with cross-domain pattern detection that creates CAPAs spanning multiple departments and owners.
Regulatory-native AI
Purpose-built on FDA CFRs, ICH guidelines, EU GMP, EMA requirements, eCTD specifications, and real enforcement data. Domain-specific intelligence trained on what regulators actually look for.
Non-negotiables.
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Built by operators
Founded by pharmaceutical quality and regulatory professionals with 16+ years inside FDA-regulated operations — biologics manufacturing, clinical oversight, and international regulatory submissions. We built the resolution workflow because we've lived the gap between finding problems and proving they're fixed.
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Detection is half the job
Anyone can flag a gap. The hard part is creating the CAPA, assigning an owner, tracking the remediation, re-scanning the fix, and documenting the entire chain for an inspector. That's what Clinplex does — the full compliance loop, not just the first step.
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Meet you where you are
Pre-IND startup or global pharma with 50 sites — same intelligence, same resolution workflow, same audit trails. No forced platform migrations. No prerequisites. Start with what you have today.
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Regulatory-grade security
Your regulatory data is competitive advantage. Protected with the same rigor 21 CFR Part 11 demands — encryption, audit trails, access controls, and data sovereignty.
What Clinplex replaces —
and what it augments.
Clinplex AI is not a QMS, not a CTMS, not a RIM system. It's the regulatory compliance layer — detection through verified resolution — your existing tools were never built to provide.
Replaces
Manual document review
Regulatory teams spending 60% of their time reading protocols and SOPs line-by-line. AI does this in 2.4 seconds with exact citations across every domain.
Spreadsheet-based CAPA tracking
Excel logs for CAPAs, submission checklists, PV timelines. They track whether something was done — never whether it was done correctly or verified against the original regulatory requirement.
Disconnected gap-to-resolution workflows
The gap report lives in one system, the CAPA in another, the task assignment in email, and the verification in someone's memory. Clinplex connects the entire chain with a Part 11 audit trail.
Periodic mock audits
Point-in-time snapshots that miss cross-domain connections. Continuous monitoring with automated resolution tracking means every day is inspection-ready.
Siloed compliance consulting
$300K–$500K engagements that cover one domain at a time and leave you with a report. Clinplex surfaces gaps across all five domains and creates the workflow to close them.
Augments
Veeva Vault / MasterControl / TrackWise
Your QMS manages document workflows. Clinplex adds regulatory content analysis, automated CAPA creation from detected gaps, and closed-loop verification that your QMS workflows can't perform.
Clinical trial management (CTMS)
Your CTMS tracks trial operations. Clinplex adds GCP compliance monitoring, protocol gap analysis, and task-assigned CAPAs routed to clinical operations teams with due dates.
Regulatory information management (RIM)
Your RIM system manages submission lifecycles. Clinplex adds eCTD content gap analysis, Module completeness scoring, and remediation task tracking to submission readiness.
Safety databases & PV systems
Your safety database manages case processing. Clinplex adds PSUR/PBRER compliance analysis, signal-to-action CAPA workflows, and risk management plan adequacy verification.
Pharma Quality leadership and Enterprise AI engineering
Start with one document.
See the full compliance loop.
Upload a GLP protocol, clinical study report, SOP, eCTD module, or PV report. Get gap analysis with automated CAPA workflow — detection through verified resolution.