Pre-clinical compliance,
verified before submission.
Your complete toxicology package reviewed against FDA and ICH requirements. Gaps identified. Calculations verified. Confidence delivered.
Limited pilot program now open
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.
Comprehensive compliance review
ClinShield analyzes your complete pre-clinical package against current FDA and ICH requirements.
- Every page of every study report reviewed
- NOAEL values extracted and verified
- MRSD calculated with complete audit trail
- Safety margins computed and compared to targets
- Study inventory checked against regulatory requirements
- Gaps identified before the FDA identifies them
You receive a comprehensive compliance report showing exactly where you stand—what is complete, what needs attention, and what the FDA will likely focus on.
What the report includes
Compliance Score
Overall readiness assessment with visual gauge showing IND preparedness at a glance
MRSD Calculation
Step-by-step calculation with full audit trail and regulatory references
Study Inventory
Complete matrix of required versus available studies for your indication
Safety Margins
Exposure multiples compared against regulatory targets with clear visualization
Finding Details
Each gap with regulatory reference and source document citation
FDA Outcome Prediction
Predicted review outcome with confidence assessment and rationale
How it works
Upload your documents
Toxicology reports, safety pharmacology, genotoxicity studies. PDF, DOCX, XLSX.
We analyze everything
Every page reviewed. Requirements checked. Calculations verified. Gaps identified.
You receive your report
Comprehensive compliance assessment with clear findings. Usually within 24 hours.
Join our pilot program
We are opening ClinShield to a limited group of early users who want to shape the future of pre-clinical compliance review.
pilot program (first 10 users)
What you get:
- Complete pre-clinical package review
- All required studies verified
- MRSD calculation with audit trail
- Safety margin analysis
- FDA outcome prediction
- Comprehensive PDF report
- 24-48 hour turnaround
What we ask in return:
- • A 30-minute feedback call to understand what works and what we can improve
- • A testimonial if you find ClinShield valuable
Your feedback directly shapes the product.
After pilot: $8,500 per protocol assessment
Built for regulatory professionals
Regulatory Affairs Directors
Ensuring IND packages meet all requirements before submission
Nonclinical Development Leads
Coordinating toxicology and safety studies across programs
Biotech Founders and CMOs
Overseeing clinical programs with limited regulatory staff
Regulatory Consultants
Supporting multiple clients with efficient compliance review
Common questions
How long does the analysis take?
Most assessments complete within 24 hours. Complex packages with 30+ documents may take up to 48 hours.
What documents should I upload?
All available toxicology study reports, safety pharmacology assessments, genotoxicity studies, and TK/PK data. Upload everything you have—we identify what is present and what may be missing.
Is my data secure?
Documents are encrypted in transit and at rest. We do not share your data or use it for training. Files are automatically deleted after 30 days.
What is included in the pilot program?
Full access to all features—the same comprehensive analysis as our standard service. Pilot users receive priority support and their feedback directly shapes product development.