AI for Pharma & Healthcare
Regulatory monitoring is time-consuming and quality documentation is overwhelming
Free discovery call — 45 minAI automates regulatory monitoring, document research, and clinical data extraction — while keeping humans in control. INYSTER deploys on Azure France with HDS-certifiable infrastructure, with no use of your data for model training.
Your daily pain points
Time-consuming regulatory watch
Hours spent scanning ANSM, EMA and FDA publications every week
Overwhelming quality documentation
Audits demand flawless traceability across hundreds of documents
Manual clinical synthesis
Clinical protocols generate mountains of textual data to synthesize
What AI changes concretely
Automated regulatory monitoring
The AI monitors regulatory publications (ANSM, EMA, FDA), extracts relevant changes for your portfolio, and generates a structured summary with required actions.
Real-time monitoring instead of monthlyQuality document assistant
Query your quality document base in plain language. The AI points to the right SOP, the right version, with associated regulatory context.
Search time divided by 5Clinical data extraction
From study reports and CRFs, the AI extracts key data and generates comparative tables. Hours of reading condensed into minutes.
Clinical summaries in minutesAnd there's more
Automated pharmacovigilance signal detection
Continuous analysis of adverse event reports to detect emerging signals. Configurable alerts by severity and frequency.
Signals detected in hours, not weeksIntelligent SOP version comparison
AI identifies changes between SOP versions, highlights modifications, and flags potential compliance gaps.
Version comparison in secondsOther use cases
- Automatic translation of regulatory submissions
- Clinical trial protocol summarization
- Batch record data extraction and validation
- Training document generation from SOPs
- Automated deviation report drafting
AI in your industry by the numbers
Frequently asked questions
Is AI compatible with GxP requirements?
Yes, with full audit trail, version control, and Azure HDS-certifiable hosting. We document the validation approach per GAMP5 principles. Every AI action is traceable and auditable, meeting inspector expectations.
How does AI handle confidential clinical data?
Azure France region, AES-256 encryption, no model training on your data. We can implement data anonymization before LLM processing. Data stays in a sovereign, isolated environment.
Can the AI understand specialized pharmaceutical terminology?
Yes, models can be fine-tuned on your specific vocabulary. RAG also uses your own document corpus as ground truth. The combination of both approaches ensures high terminological accuracy in your business context.
What's the ROI timeline for regulatory intelligence automation?
Typical ROI within 3–6 months. One pharma client saved 2 FTE-days per week on regulatory surveillance alone. The gain also includes reduced non-compliance risk and the ability to reassign qualified staff to higher-value work.
Is my data secure?
Yes. We deploy on Microsoft Azure, France region. Your data stays in Europe, encrypted at rest and in transit (AES-256). No data is used to train models — this is contractually guaranteed by Microsoft. For health data, Azure is HDS-certifiable.
100% GDPR
Data hosted in France
Security
End-to-end encryption
Dedicated support
Personalized guidance
Let's identify your AI use cases
- Understand your operational pain points
- Identify 2-3 high-impact AI use cases
- Estimate the ROI and associated budget