Enforcement databases tell you what went wrong. We catch what will go wrong — before regulators see your filing. Automated screening across biologics, medical devices, and pharmaceuticals.
You spend months preparing a submission. Then regulators come back with questions that could have been anticipated — if you knew what they were looking for.
The patterns are hiding in plain sight: warning letters, 483s, CRLs, EPAR assessments. These aren't random — they're systematic documentation gaps that keep appearing across submissions. Our platform screens for them before you file.
Sigmatwin screens your CMC documentation against 60+ deficiency themes derived from real regulatory enforcement actions. You see exactly where your submission is weak — and get specific guidance on what to fix.
This isn't another enforcement database. It's a pre-submission screening engine that tells you what FDA, EMA, or PMDA will likely flag — before they see your filing.
No consultants. No weeks of manual review. Just systematic screening against real regulatory patterns.
Drop your Module 3 sections, design dossiers, or quality documentation
Choose FDA, EMA, PMDA, or any combination of 11 agencies
AI + rule-based analysis checks 60+ deficiency patterns
Prioritized findings with citations and remediation guidance
We're transparent about what this platform does — and what it doesn't.
We don't "predict" deficiencies for your specific product. We check whether your documentation addresses the themes that regulators consistently cite across the industry — regardless of product type.
The platform screens for systematic documentation gaps: missing data, incomplete validation, unaddressed requirements. These are the preventable issues that appear in 74% of CMC-related CRLs.
CMC requirements are largely standardized. FDA doesn't stop requiring process validation because your drug is novel. We screen against requirements that apply to every submission in that category.
Each theme maps to specific CFR citations or ICH guidelines. When we flag "Process Validation incomplete," we're checking: Are 3 batches documented? Is commercial scale addressed? Are CPPs defined?
"Commercial scale validation not demonstrated. See 21 CFR 211.100, FDA Process Validation Guidance (2011)."
We can't assess whether your specific analytical method is scientifically sound
Clinical review issues are outside CMC scope
Regulators make final decisions — we reduce preventable gaps
Substantial equivalence requires case-by-case analysis
"We don't guarantee approval. We guarantee you won't get rejected for preventable documentation gaps that others have already been cited for."
Each module has specialized themes, jurisdiction weights, and regulatory citations tuned for that vertical.
Screen CMC sections for monoclonal antibodies, cell therapies, gene therapies, vaccines, and recombinant proteins.
Screen design dossiers and technical files for diagnostics, implantables, software as medical device, and combination products.
Screen CMC sections for NCEs, generics, 505(b)(2), and complex formulations against global requirements.
Manual gap assessments cost $50k and take weeks. We automated it — across 11 jurisdictions.
Catch CMC gaps before regulators do. Fewer information requests. Faster approvals.
Gap assessments that used to cost $50k+ from consultants. Now automated and repeatable.
See enforcement patterns across your sector. Understand where the industry struggles.
One screening covers FDA, EMA, PMDA, and more. See where requirements diverge.
Show leadership exactly which gaps are high-risk. Data-driven investment decisions.
Re-screen after revisions. See your deficiency risk drop. Document your due diligence.
Our screening rules aren't theoretical. They're derived from real warning letters, 483s, complete response letters, and assessment reports across all three verticals.
Every theme maps to specific regulatory citations. Every risk score is calibrated against actual enforcement patterns. This is intelligence from the field — not consultant opinion.
Enterprise-grade security and compliance controls built in from day one. Your submissions never train our models. Your data never leaves your control.
AES-256 encryption at rest and TLS 1.3 in transit. Your documents are encrypted the moment they touch our system.
Built for GDPR, SOC2, HIPAA, and 21 CFR Part 11. Audit-ready documentation and controls out of the box.
Blockchain-style audit logging with cryptographic chaining. Every access logged, every action traceable.
Full data portability and right to erasure. Export or delete your data anytime. We don't hold your submissions hostage.
Choose where your data lives — US, EU, or APAC. Meet local data sovereignty requirements without compromise.
Your submissions never train our AI. Your competitive intelligence stays yours. Period.
Compliance frameworks: GDPR · SOC2 Type II · HIPAA · 21 CFR Part 11 · ISO 27001
Enforcement databases are excellent for post-inspection analysis and supplier due diligence. Sigmatwin is different — we screen YOUR documents against deficiency patterns BEFORE you submit. They tell you what happened to others; we catch what will happen to you. We're complementary, not competitive.
We don't predict product-specific scientific questions — those require regulatory expertise. What we screen for are DOCUMENTATION gaps: the systematic issues in 74% of CMC-related CRLs. Process validation requirements don't change because your drug is novel. Stability data expectations don't disappear for first-in-class. We check themes regulators consistently ask about — regardless of product type.
Yes — the data is public and the technology isn't magic. But we're focused exclusively on pre-submission screening while they're focused on post-inspection analysis. Different buyer (Regulatory Affairs vs Quality), different use case, different sales motion. By the time they pivot, we'll have deeper vertical expertise and validated customer workflows.
FDA (CBER, CDER, CDRH), EMA, PMDA (Japan), MHRA (UK), Health Canada, TGA (Australia), ANVISA (Brazil), NMPA (China), CDSCO (India), Swissmedic, and COFEPRIS (Mexico). Each vertical has jurisdiction-specific theme weights calibrated to local enforcement patterns.
PDF, Word, and structured XML (eCTD Module 3 format). You can upload individual sections or entire CMC packages. Our parser extracts the relevant content automatically.
Our themes are derived from real enforcement actions with specific regulatory citations. We don't claim to catch every possible deficiency — but we systematically check against the patterns that appear most frequently in actual CRLs, warning letters, and assessment reports. Think of it as a pre-flight checklist, not a crystal ball.
Screening checks documentation completeness: "Did you include process validation data?" Scientific review assesses adequacy: "Is your validation approach scientifically sound?" We do the first — systematically and automatically. The second still requires human expertise and regulatory judgment.
Yes. Upload their CMC documentation or quality agreements and screen against relevant themes. You'll see exactly where their processes may have gaps before you commit to a partnership.
We continuously ingest new warning letters, 483s, and assessment reports. Theme weights are recalibrated quarterly based on enforcement trends. Enterprise customers can also ingest their own proprietary data to customize screening.
No. Regulators make final approval decisions based on many factors beyond CMC documentation. What we guarantee is that you won't be rejected for preventable documentation gaps that others have already been cited for. We reduce risk; we don't eliminate it.
See exactly where your CMC documentation is weak — before regulators tell you. Request a demo with your actual documents.