Regulatory Tools
Purpose-built utilities for pharma, biotech, and medical device regulatory teams. Browser-based, no account required, files never leave your session.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.