IONI scans your pharmaceutical documentation — SOPs, clinical protocols, submission files — and maps them to regulatory frameworks like GxP, ICH, and FDA 21 CFR.
Step 2
Activate Regulatory Monitoring
IONI watches key regulatory bodies (FDA, EMA, PMDA, etc.) and industry frameworks, customized to your operational scope.
Step 3
Get Alerts + AI Insights
Receive real-time alerts on changes that impact your products, with AI-generated analysis and cited regulatory sources.
Step 4
Close Gaps, Stay Compliant
Use AI-generated actions to revise documents, update processes, and maintain audit-ready compliance at all times.
Benefits
Reduce Risk of Non-Compliance
Accelerate Regulatory Submissions
Cut Manual Review Time by 70%
Ensure Global Regulatory Alignment
Boost Audit Readiness Across Teams
Streamline Pharma AI Adoption with No-Code Setup
Security You Can Trust
Data encrypted at rest and in transit
Secure infrastructure with enterprise-grade controls (SOC 2, ISO 27001) - in progress
Role-based permissions & full audit logging
Book a free consultation with our expert!
Join hundreds of food businesses who have simplified their compliance with our AI-powered solution.
IONI tracks global regulators including the FDA, EMA, MHRA, PMDA, Health Canada, ICH, and WHO.
Is IONI Secure Enough for Regulated Environments?
Absolutely. We meet enterprise-grade security standards, including data encryption, audit trails, and compliance with GxP expectations.
How Fast Can We Get Started?
Most teams are up and running within days — no technical setup required.
Can IONI’s Pharmaceutical Regulatory Software be Customized for Our Therapeutic Area?
Yes, IONI is highly configurable. Whether you're in oncology, biotech, or generics, our pharmaceutical regulatory software can be tailored to your product class, regulatory jurisdiction, and internal workflow.
Can I use IONI to Prepare for Regulatory Inspections or Audits?
Absolutely. IONI generates complete documentation sets, flags compliance gaps, and maintains real-time audit trails to help you stay inspection-ready at all times.
Does IONI Integrate with Document Management Systems and QMS Platforms?
Yes, IONI can integrate with DMS, QMS, and other enterprise systems through secure APIs—creating a seamless compliance ecosystem.
Is IONI Suitable for Both Clinical and Commercial-Stage Companies?
Yes. Whether you're in early-phase clinical development or managing post-market surveillance, IONI adapts to your compliance maturity and regulatory obligations.
Can IONI Help Manage Changes in Regulatory Requirements Across Different Regions?
Yes, IONI continuously monitors global regulatory changes and alerts your team, helping you stay compliant with evolving standards in each jurisdiction.
