Pre-Clinical Safety Intelligence
Know your before FDA does.
Upload your pre-clinical package. ClinShield reviews it against every FDA and ICH rule that triggers a hold — MRSD calculated, gaps flagged, risk scored.
The analysis that used to take consultants six months. Done in one afternoon.
Your documents are processed and immediately discarded.
Never stored, never used for training, never shared.
The cost of getting it wrong
- • Clinical hold: $2M to $10M in delays
- • 6+ months lost
- • Consultants charge $50K+ and still take 6 weeks
ClinShield gives you clarity before any of that.
The challenge of IND preparation
Every regulatory professional knows the weight of submission day.
The fear of missing something
You have reviewed the toxicology package multiple times. Cross-referenced ICH M3 guidance. But the doubt remains: did something slip through? One overlooked requirement can trigger a clinical hold that delays everything by 12 months or more.
Complexity with consequences
Dozens of study reports. Multiple species and duration combinations. Exposure margins across dose levels. The complexity is manageable. The cost of an error is not. A miscalculated MRSD or missed safety study can derail years of development.
The time pressure
Submission deadlines are fixed. Study reports arrive late. Your team needs your assessment. Being thorough takes time you may not have. Being fast risks missing something critical. You have always had to choose.
How it works
Upload
Drag and drop your pre-clinical safety documents (up to 25 documents)
Process
ClinShield validates against FDA/ICH requirements using deterministic rules
Report
Get findings, citations, MRSD calculations, and action items. Every finding traceable to a page number.
See What You'll Get
A real readiness report from ClinShield. Results you can verify.
Program Coverage
Annual regulatory coverage for every drug in your pipeline. Not reports — continuous protection.
A regulatory consultant charges $20-40K for one manual review that takes 4-6 weeks. Active Coverage gives you unlimited assessments for a full year.
Launchpad
$30,000
/program/year
For teams starting their journey to first-in-human trials
What you get
- 2 full ClinShield assessments per year per program
- Findings mapped to FDA/ICH regulatory requirements
- Page-level citations for every finding
- MRSD calculation with full audit trail
- Compliance score and clinical hold risk prediction
- Audit-ready PDF report for each assessment
- Review of up to 25 documents per assessment
- Email support
Best for
- Series A biotechs with their first compound
- Teams testing regulatory readiness before engaging consultants
- Early-stage programs entering IND-enabling studies
Active Coverage
$60,000
/program/year
For teams actively preparing for FDA submission
What you get
- Everything in Launchpad, plus:
- Unlimited assessments — re-run every time new data arrives or documents change
- Delta reports showing exactly what changed since your last assessment
- Dedicated onboarding and quarterly review calls
- Priority processing
- Pre-submission meeting preparation support — your ClinShield report formatted for FDA briefings
- Rule updates applied retroactively — when guidelines change, your previous assessments get re-scored
Best for
- Series A-B biotechs actively preparing IND submissions
- Teams with regulatory consultants who want a second set of eyes
- Programs within 6 months of planned submission
Full Lifecycle
Starting at $100,000
/program/year
For multi-program companies that need continuous coverage across their entire pipeline
What you get
- Everything in Active Coverage, plus:
- Phase 1-3 clinical compliance monitoring (when available)
- NDA/BLA submission readiness assessment (when available)
- Multi-program dashboard — see all your compounds in one view
- API access for integration into existing regulatory workflows
- Custom rule configurations for company-specific SOPs
- Dedicated account manager
- Quarterly regulatory landscape briefings
Best for
- Series B+ biotechs with multiple active compounds
- Platform companies with growing pipelines
- Teams preparing for IND and beyond
Early Access
Our first 10 customers get 14 months of coverage for the price of 12 on any tier. Limited spots remaining.
Apply for Early AccessBuilt by Experts Who've Been There
Regulatory science meets engineering. We built the tool we wished existed.
Karaiman Feroz
CEO & Regulatory Expert
Former scientist with hands-on experience reviewing pre-clinical toxicology packages
"Knows what FDA actually looks for because she's done it manually hundreds of times."
Hamza Shafiq
CTO & Technical Architect
Built the entire ClinShield platform, combining AI with deterministic regulatory logic
"Built the system that turns regulatory expertise into software."
We spent years living with last-day IND jitters, hoping we'd make the breakthrough in time. With ClinShield, that uncertainty disappears forever.
Karaiman Feroz
CEO & Co-Founder
Data Security
No document storage
Documents are processed and deleted. We do not retain your files.
No training on your data
Your submissions are never used to train models.
Encryption everywhere
TLS 1.3 in transit, AES-256 at rest.
NDA-ready
We will sign your NDA before you upload anything.
Frequently asked questions
What if ClinShield misses something?
ClinShield is a first-pass tool, not a replacement for human review. If you are using a consultant and they catch something we missed, your next assessment is free.
How is this different from ChatGPT?
ChatGPT does not know FDA regulations, hallucinates, and does not cite sources. ClinShield uses deterministic rules and every finding links to a page number.
Why should I trust AI with regulatory work?
You do not trust us, you verify. Every extraction links to the source page. Low-confidence items get flagged. It is auditable.
What is Program Coverage?
Coming soon. Instead of paying per report, you pay for continuous coverage of a drug program. Re-runs anytime, rule updates included, deltas flagged automatically.