Full feature set
Sutra Regulatory
A complete view of what Sutra Regulatory does. Everything here is covered in detail during a discovery call.
- Submission timeline builder with dependency mapping
- Milestone tracking with owner assignment and SLA alerts
- Readiness checkpoint framework with defined gate criteria per submission type
- Rolling readiness score updated continuously as documents are completed
- Critical path identification
- Multi submission portfolio view
- Region and authority specific timeline templates for FDA, EMA, PMDA, MHRA, Health Canada, TGA, ANVISA, and NMPA
- Submission calendar with agency PDUFA date tracking
- Section level completeness check against eCTD module structure
- Missing artifact identification with severity classification across blocking versus advisory
- Document status tracking per section across draft, in review, approved, superseded
- Gap prioritization ranked by submission risk and time to resolve
- Automated gap summary report
- Completeness trend tracking
- Submission type specific templates for IND, NDA, BLA, MAA, ANDA, 510(k)
- Section ownership assignment
- eCTD module structure compliance check aligned to ICH M8
- Document naming convention validation
- Hyperlink integrity check
- Sequence numbering validation
- Backbone file completeness check
- Technical deficiency report with resolution guidance
- Claim consistency detection across modules
- Date and timeline consistency across study records, manufacturing dates, and regulatory history
- Terminology standardization that detects variant terms for the same concept
- Dosage and specification consistency between CMC and clinical sections
- Version and document reference integrity
- Contradiction detection that surfaces two documents making incompatible claims
- Consistency check report with source document links
- Authority coverage across FDA (CDER, CBER, CDRH), EMA, PMDA, MHRA, Health Canada, TGA, ANVISA, NMPA
- Authority specific requirement mapping per submission type
- Region specific gap detection
- Regional submission strategy comparison
- Authority specific formatting and structure requirements
- Market entry sequence guidance based on package readiness
- Real time monitoring of FDA, EMA, PMDA, MHRA, and other authority guidance publications
- Relevance matching against open submissions
- Guidance change alerts
- Searchable guidance library
- Deficiency letter ingestion and classification by type, module, and urgency
- AI assisted response argument drafting with source cited evidence
- Response package assembly tracking open items versus drafted responses
- Response SLA tracking
- Complete response letter analysis
- Change type classification per authority specific criteria
- Submission obligation assessment that maps a given change to required filing type per target authority
- Change impact analysis identifying affected dossier sections
- Lifecycle submission tracker for CBE 30, CBE 0, PAS, and variation submissions
- Module level readiness score on a 0 to 100 scale
- Overall submission readiness score as a weighted composite
- Score inputs across document completeness, consistency check results, open gaps, review action status, authority specific coverage
- Score history and trend over time
- Score drill down to contributing factors per module
- Readiness gate criteria
- Readiness report export
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