See beyond
the surface of
biotech intelligence
Instant insights
Instant insights
Access regulatory insights and drug data instantly,
wherever you are
The most intuitive platform we've used, helping us make faster, data-driven decisions with confidence.
The most intuitive platform we've used, helping us make faster, data-driven decisions with confidence.
The most intuitive platform we've used, helping us make faster, data-driven decisions with confidence.
15x
15x
faster compliance reviews
faster compliance reviews
70%
70%
fewer submission errors
fewer submission errors
Streamline your regulatory operations with intelligence
Submission Management
Seamlessly track filings, forms, and agency interactions in one central platform.
Real-Time Visibility
Surface compliance risk and key indicators as data flows across your pipeline.
Streamline your regulatory operations with intelligence
Submission Management
Seamlessly track filings, forms, and agency interactions in one central platform.
Real-Time Visibility
Surface compliance risk and key indicators as data flows across your pipeline.
Streamline your regulatory operations with intelligence
Submission Management
Seamlessly track filings, forms, and agency interactions in one central platform.
Real-Time Visibility
Surface compliance risk and key indicators as data flows across your pipeline.
Transforming biotech with AI-powered decision support
Trial Intelligence
Visualize study trends, anomalies, and protocol metadata in real time.
ML-Driven Impact
Simulate drug performance and forecast regulatory outcomes instantly.
Transforming biotech with AI-powered decision support
Trial Intelligence
Visualize study trends, anomalies, and protocol metadata in real time.
ML-Driven Impact
Simulate drug performance and forecast regulatory outcomes instantly.
Transforming biotech with AI-powered decision support
Trial Intelligence
Visualize study trends, anomalies, and protocol metadata in real time.
ML-Driven Impact
Simulate drug performance and forecast regulatory outcomes instantly.
Enhance submission readiness at machine speed
“Kalypsis transformed our regulatory cycle. It’s intuitive, fast, and reduces delays by weeks.”
Enhance submission readiness at machine speed
“Kalypsis transformed our regulatory cycle. It’s intuitive, fast, and reduces delays by weeks.”
Enhance submission readiness at machine speed
“Kalypsis transformed our regulatory cycle. It’s intuitive, fast, and reduces delays by weeks.”
“What used to take weeks now runs overnight — your AI platform has transformed how we prepare regulatory packets.”
Dr. Victor Santos
Medical Doctor | Cloudwatch
“What used to take weeks now runs overnight — your AI platform has transformed how we prepare regulatory packets.”
Dr. Victor Santos
Medical Doctor | Cloudwatch
“What used to take weeks now runs overnight — your AI platform has transformed how we prepare regulatory packets.”
Dr. Victor Santos
Medical Doctor | Cloudwatch
Advantages
Advantages
Advantages
From trial data to FDA-ready output, our platform gives you the tools
to stay ahead
Enhance submission readiness
Rapidly convert trial data, lab reports, and protocol drafts into FDA-compliant IND, BLA, and NDA documentation — auto-tagged, formatted, and audit-trail enabled. Reduce manual rework and accelerate preclinical to regulatory submission timelines.
Enhance submission readiness
Rapidly convert trial data, lab reports, and protocol drafts into FDA-compliant IND, BLA, and NDA documentation — auto-tagged, formatted, and audit-trail enabled. Reduce manual rework and accelerate preclinical to regulatory submission timelines.
Enhance submission readiness
Rapidly convert trial data, lab reports, and protocol drafts into FDA-compliant IND, BLA, and NDA documentation — auto-tagged, formatted, and audit-trail enabled. Reduce manual rework and accelerate preclinical to regulatory submission timelines.
Predictive regulatory intelligence
Deploy ML models that forecast approval pathways, identify optimization opportunities, and surface strategic insights before they become critical decisions. Train your regulatory approach on competitive intelligence and real-time data — all powered by enterprise-grade AI.
Predictive regulatory intelligence
Deploy ML models that forecast approval pathways, identify optimization opportunities, and surface strategic insights before they become critical decisions. Train your regulatory approach on competitive intelligence and real-time data — all powered by enterprise-grade AI.
Predictive regulatory intelligence
Deploy ML models that forecast approval pathways, identify optimization opportunities, and surface strategic insights before they become critical decisions. Train your regulatory approach on competitive intelligence and real-time data — all powered by enterprise-grade AI.
Clinical quality monitoring at AI scale
Continuously track protocol adherence, patient safety metrics, and trial data integrity in real time. Detect anomalies, ensure submission-grade quality, and reduce the risk of FDA rejections — all with AI-powered monitoring tools purpose-built for complex studies.
Clinical quality monitoring at AI scale
Continuously track protocol adherence, patient safety metrics, and trial data integrity in real time. Detect anomalies, ensure submission-grade quality, and reduce the risk of FDA rejections — all with AI-powered monitoring tools purpose-built for complex studies.
Clinical quality monitoring at AI scale
Continuously track protocol adherence, patient safety metrics, and trial data integrity in real time. Detect anomalies, ensure submission-grade quality, and reduce the risk of FDA rejections — all with AI-powered monitoring tools purpose-built for complex studies.
Enterprise Regulatory Intelligence Built for Breakthrough Therapeutics
Accelerate your development timelines with AI that understands the complexity of innovation and protects your IP like it's mission-critical.
Your data’s best defense
Your data is protected with enterprise-grade encryption. Our platform delivers ironclad encryption with full healthcare compliance.
Your data’s best defense
Your data is protected with enterprise-grade encryption. Our platform delivers ironclad encryption with full healthcare compliance.
Your data’s best defense
Your data is protected with enterprise-grade encryption. Our platform delivers ironclad encryption with full healthcare compliance.
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Explore the science behind Kalypsis
Get started
Your Journey to Intelligent Biotech Starts Here
Get started
Your Journey to Intelligent Biotech Starts Here
Get started
Your Journey to Intelligent Biotech Starts Here