Your compliance
engine,
not your advisor
AI-powered GAP assessment, findings, corrective actions and inspection-ready reporting - with expert review on demand. Try it now, no sign up needed.
Used by QA Directors & Regulatory Leads
across pharma, biotech & medical devices
Regulatory coverage
11 frameworks & jurisdictions
ICH Guidelines
ICH QualityQ-Series
ICH EfficacyE-Series
ICH SafetyS-Series
ICH MultidisciplinaryM-Series
Regional regulators
FDAUnited States
EU GMPEuropean Union
SAHPRASouth Africa
SAPCSouth Africa
International standards
WHO
PIC/S
ISPE / GAMP 5
ALCOA+
ISO 13485
— T H E P L A T F O R M
Evidence in. Inspection-ready out.
Five structured workflow stages. AI accelerates every step.
Qualified humans govern every compliance determination.
01
Evidence intake
AI
02
Control review
AI
03
Findings
AIHuman
04
Actions
AI
05
Report
AIHuman
— C L I E N T O U T C O M E S
Results that hold up under scrutiny.
All testimonials anonymized – standard in regulated industries
★★★★★
US API Manufacturer
"RelyAInt identified 47 compliance gaps we had no visibility of - and delivered the full register 18 days before our FDA re-inspection. Zero repeat 483 observations."
★★★★★
South African Solid Dose Site
"The AI surfaced anomalies across 18,000 batch records in days. The structured CAPA plan - verified by the RelyAInt team - got our export license renewed by SAHPRA."
★★★★★
EU-based CDMO · Sterile manufacturing site
"We were 6 weeks from our first EMA inspection with a validation package that hadn't been touched in 3 years. RelyAInt ran a full CSV gap analysis, bridged us to the current CSA framework, and delivered an inspection-defensible traceability matrix. We passed first attempt."
★★★★★
UK combination product startup
"As a startup building our QMS from scratch, we didn't have the internal expertise to navigate dual FDA and MHRA requirements simultaneously. RelyAInt mapped the overlap, drafted 22 priority SOPs, and got us submission-ready 6 weeks ahead of our target. Worth every cent."
G E T S T A R T E D
Inspection-ready starts here.
Try the compliance engine above.
No commitment required
✓ No obligation ✓ Fully confidential ✓ Response within 48 hours ✓ Human-reviewed