In life sciences and health technology, regulatory compliance is not just a process. It is a critical enabler of patient safety, market access, and business continuity. As global regulations continue to evolve, organizations face increasing pressure from fragmented standards, manual documentation, and complex audit requirements that slow innovation and delay time to market.

i‑QARA is an AI-driven regulatory compliance platform designed to simplify and accelerate compliance across the end-to-end product lifecycle. By applying Generative AI, intelligent automation, and continuous regulatory intelligence, i‑QARA transforms traditionally labor-intensive compliance activities into streamlined, proactive workflows. The platform supports intelligent dossier authoring, automated labeling verification, and real-time monitoring of global regulatory changes, helping organizations always remain audit ready.

Built for medical device and healthcare enterprises, i‑QARA enables data integrity, risk mitigation, and regulatory agility at scale. With predictive compliance insights, AI-powered deviation detection, and embedded governance, the platform reduces operational burden on quality and regulatory teams while improving submission accuracy and speed. By shifting compliance from a reactive obligation to a strategic advantage, i‑QARA helps life sciences organizations bring safe, compliant, life‑saving products to market faster and with greater confidence.

GenAI Content Authoring

Automate the drafting of regulatory dossiers and clinical study reports.

Proactive Vigilance

Predict safety risks and manage post-market surveillance to protect patients.

Automated Labeling

Achieve exceptional accuracy via OCR-driven real-time deviation detection.

Services

Accelerate Dossier Compilation

Automate regulatory document creation to align with global standards.

Detect Label Deviations

Identify real-time discrepancies in product labels using intelligent OCR.

Predict Post-market Risks

Ensure device safety through AI-driven risk prediction and detection.

Monitor Global Standards

Stay audit-ready with LLMs tracking FDA and EU MDR updates instantly.

Trigger Incident Workflows

Generate automated incident reports to ensure prompt compliance actions.

Track Regulated Materials

Monitor supply chain materials like PFAS to ensure ongoing adherence.

Contact Us