Regulatory Tools
Free Tools for Regulatory Teams
Purpose-built utilities for pharma, biotech, and medical device regulatory teams. Browser-based, no account required, files never leave your session.
eCTD Validator
Validate eCTD structure in 60 seconds
Upload an eCTD sequence and get structural, lifecycle, and metadata validation against the ICH eCTD v4.0.0 specification and the FDA Technical Conformance Guide. Files never leave your browser.
- 358+ structural and technical checks
- Lifecycle operation conflict detection
- Prioritized findings grouped by severity
- Redacted structural report you can export for internal QA
ROI Calculator
Quantify the cost of submission rework
Estimate the annual cost of review-cycle delays, validation rework, and coordination overhead across your regulatory programs. Built on industry benchmarks for FDA and global filings.
- Program-type breakdown (IND, NDA, BLA, 510(k))
- Review cycle, validation, and handoff cost modeling
- Exportable summary for finance conversations
- Benchmarked against industry time studies
PDUFA Calendar
Track every FDA PDUFA date that matters
Searchable calendar of FDA PDUFA dates across approved and pending drug programs. Filter by therapeutic area, sponsor, submission type, and review status.
- PDUFA dates across CDER and CBER programs
- Filter by therapeutic area and review division
- Historical PDUFA outcomes for benchmarking
- Sponsor and product-level detail
FDA Purple Book
Search FDA-licensed biologics and patents
Browse official FDA Purple Book product data for biologics, biosimilars, interchangeables, reference products, exclusivity dates, marketing status, and patent-list records.
- FDA monthly downloads and Advanced Search source data
- BLA, applicant, product, center, and license-type filters
- Reference-product grouping and patent-list detail
- Source provenance, sync freshness, and version history
FDA Orange Book
Search approved drugs, generics, and TE codes
Browse official FDA Orange Book data for approved drug products: brand (NDA) and generic (ANDA) applications, therapeutic-equivalence codes, reference-listed drugs, listed patents, and marketing exclusivity.
- Built from the official FDA Orange Book data file
- NDA/ANDA, marketing status, TE code, and dosage-form filters
- Brand-and-generic grouping by active ingredient
- Listed patents and marketing exclusivity with expiry dates
FDA Inspection Database
Search inspections, citations, firms, and published 483s
Unified FDA-published final-action inspection data with conservative links between inspections, citations, OII reading-room 483 records, FEI numbers, and firm history.
- Inspection classifications across NAI, VAI, and OAI
- CFR-linked inspection citation search
- Published 483 records from the OII FOIA Reading Room
- Firm and FEI-level inspection history
FDA 483 Database
Search published FDA Form 483 records by firm and date
Browse FDA-published Form 483 inspection records from the OII FOIA Electronic Reading Room — by firm, FEI number, establishment type, and country — with dedicated year and month archives.
- Published Form 483s from the OII FOIA Reading Room
- Browse by year and month (e.g. 2026, then June 2026)
- Firm, FEI, establishment type, and country detail
- Source-linked to the FDA record for every row
510(k) Predicate Database
Find candidate predicate devices in the FDA 510(k) database
Search the public FDA 510(k) clearance database by device name or product code to scope candidate predicate devices for a Premarket Notification. Live openFDA data, source-linked to FDA.gov.
- Search the FDA 510(k) clearance record live
- Click any product code to list every cleared device of that type
- K-number, applicant, decision date, and decision for each result
- Every result links to its authoritative FDA.gov record
Regulatory Alerts
Monitor FDA and global guidance changes
Track FDA Federal Register notices, CDER/CBER/CDRH guidance, ICH workstream releases, and Health Canada notices. Filter by product scope and therapeutic area.
- FDA Federal Register notice ingestion
- ICH, EMA, Health Canada, PMDA monitoring
- Filter by therapeutic area and submission type
- Direct links to source documents
Need more than a one-off tool?
The Assyro platform combines continuous validation, AI-assisted drafting, regulatory intelligence, and submission lifecycle management into one workspace. If you are running 2+ active programs and outgrowing point utilities, see how teams compress review cycles and catch defects earlier without adding headcount.