Regulatory intelligence across the entire drug lifecycle.
From discovery through pharmacovigilance — AI-powered compliance analysis against FDA, ICH, EMA, and global regulatory frameworks. Upload documents or integrate your systems. Same intelligence either way.
Clinplex AI is a regulatory intelligence platform that pharmaceutical, biotech, and medical device teams use across the entire drug lifecycle — from discovery and preclinical compliance through clinical trial regulations (IND/NDA/BLA), GMP manufacturing, regulatory submissions (eCTD Modules 1–5), and post-market pharmacovigilance. Upload documents directly or integrate with platforms like Veeva Vault, MasterControl, TrackWise, and SAP QM. Every record analyzed against FDA 21 CFR, ICH guidelines, EU GMP, and EMA requirements with citation-level traceability and severity scoring.
One platform. Every phase.
From molecule to market to monitoring.
Most compliance tools cover one domain. Clinplex spans the entire regulatory landscape — so gaps that cross boundaries don't go undetected.
Discovery & Preclinical
GLP compliance (21 CFR 58), research protocol documentation, data integrity controls, IND-enabling study readiness.
Clinical Trials
GCP compliance (ICH E6), IND/CTA submissions, clinical site documentation, DSMB reporting, investigator brochure adequacy.
Manufacturing & Quality
GMP compliance (21 CFR 210/211/820), batch records, deviations, CAPAs, process validation, environmental monitoring.
Regulatory Submissions
eCTD Modules 1–5, NDA/BLA/ANDA assembly, CMC documentation, clinical summaries, FDA/EMA submission readiness scoring.
Post-Market & PV
Pharmacovigilance signal detection, PSUR/PBRER compliance, adverse event investigation, risk management plan evaluation, REMS monitoring.
Upload a document.
Or connect your systems.
Same intelligence either way.
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 clinical trial management systems for continuous monitoring.
Regulatory-native AI
Every record evaluated against the full regulatory landscape — FDA CFRs, ICH guidelines, EU GMP, EMA requirements, and eCTD specifications. Exact citations. Severity scoring. Cross-domain pattern detection that connects manufacturing gaps to submission risks to PV signals.
Fix before they find
Prioritized gap reports with remediation roadmaps across every lifecycle stage. Submission readiness scoring. Inspection risk prediction. Pharmacovigilance signal correlation. One view across the entire regulatory posture.
Deep intelligence in
every domain that matters.
Each domain has its own regulatory framework, its own document types, and its own inspection patterns. Clinplex knows them all.
Discovery & Preclinical
GLP protocol compliance, IND-enabling study documentation, research data integrity under 21 CFR Part 11, toxicology study report completeness, and preclinical-to-clinical regulatory transition readiness.
Clinical Trials & GCP
Clinical protocol compliance, informed consent adequacy, investigator brochure completeness, IND/CTA submission readiness, DSMB documentation, site audit preparation, and ICH E6(R2) GCP adherence.
Manufacturing & GMP
Batch record review, deviation investigation adequacy, CAPA root cause rigor, process validation documentation, environmental monitoring, cleaning validation, and cross-site pattern detection.
Regulatory Submissions
eCTD Module completeness scoring, CMC section gap analysis, clinical overview and summary adequacy, Module 2.5/2.7 cross-referencing, NDA/BLA/ANDA assembly verification, and FDA/EMA submission readiness.
Pharmacovigilance
Adverse event investigation compliance, PSUR/PBRER documentation adequacy, signal detection analysis, risk management plan evaluation, REMS program monitoring, and CIOMS reporting completeness.
Cross-Domain Intelligence
Where most platforms stop at one domain, Clinplex connects signals across all five — manufacturing deviations that impact submission timelines, PV signals that require labeling updates, clinical findings that change GMP requirements.
What changes when
you can see everything.
When regulatory risk is visible across every domain — continuously, not periodically — the entire compliance posture shifts.
Faster gap detection
Issues surfaced in hours, not the 3–6 months periodic audits take.
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 in seconds.
From first IND filing
to global PV operations.
Pre-clinical & emerging biotech
Building your regulatory infrastructure from scratch? Upload your GLP protocols, IND-enabling studies, and quality documentation. Know exactly where gaps exist before your first FDA interaction.
Clinical-stage companies
Navigating IND submissions, site audits, and GCP compliance? Clinplex evaluates your clinical documentation, protocols, and investigator brochures against ICH E6 and FDA requirements.
Commercial pharma & CDMOs
Managing GMP manufacturing, regulatory submissions, and post-market obligations across multiple products and sites. Continuous monitoring with cross-domain pattern detection your QMS can't do.
Regulatory affairs & PV teams
Preparing NDA/BLA submissions, managing eCTD modules, running pharmacovigilance programs. Clinplex scores submission readiness and monitors PV compliance against FDA and EMA requirements.
Regulatory intelligence,
explained.
AI-Powered Regulatory Gap Analysis
How AI replaces manual audits with continuous regulatory gap detection across the drug lifecycle.
Read →FDA 483 Prevention with AI Pattern Detection
The most common 483 citations and how AI identifies the patterns that predict them.
Read →AI + Veeva, MasterControl & TrackWise
How regulatory intelligence integrates with enterprise systems for continuous monitoring.
Read →Pharmaceutical RegTech 2025
Where regulatory intelligence fits across the pharmaceutical technology stack.
Read →Start with one document.
From any stage of the lifecycle.
Upload a clinical protocol, SOP, eCTD module, or PV report for a free regulatory gap analysis. Or schedule a demo to see the full platform.