IONI’s pharma regulatory software tracks global regulators including the FDA, EMA, MHRA, PMDA, Health Canada, ICH, and WHO. Our platform is designed to support life sciences regulatory compliance, ensuring pharmaceutical, biotech, and medical device companies remain aligned with both regional and international requirements.

Absolutely. IONI is built for pharmaceutical regulatory compliance software environments and adheres to enterprise-grade security standards. This includes end-to-end encryption, detailed audit trails, role-based access controls, making it safe for highly regulated life sciences workflows.

Most teams are fully operational with IONI within days. Our pharma AI platform requires no heavy technical setup, allowing your compliance and regulatory teams to quickly benefit from automation and intelligence-driven insights.

Absolutely. IONI automates inspection readiness by generating complete documentation sets, flagging compliance gaps, and maintaining real-time audit trails. With our pharmaceutical regulatory compliance software, you’re always prepared for inspections from regulators such as the FDA, EMA, or Health Canada.

Yes. IONI supports organizations at every stage of development. From early-phase clinical trials to post-market surveillance, our life sciences regulatory compliance software adapts to your compliance maturity and evolving obligations.

Yes. IONI continuously monitors global regulatory changes and provides AI-prioritized alerts to your team. Our pharma AI-driven platform helps you stay aligned with evolving standards across all jurisdictions, reducing risk and ensuring smooth compliance operations worldwide.