DECISION-OS Contact

Regulatory intelligence built on primary FDA data.

Decision-OS surfaces patterns in public FDA records — inspections, enforcement actions, Drug Master Files, Orange Book — that manufacturers' internal teams don't aggregate. Every finding traces to a primary source.

Capability

Primary-source ingestion

Decision-OS ingests directly from FDA public data: the Inspection Classification database, Warning Letters, the Drug Master File registry, the Orange Book, and enforcement records. No third-party aggregators.

Pattern analysis

Statistical and time-series methods applied across facilities, inspection histories, and enforcement timelines — surfacing patterns that only become visible when public records are aggregated systematically.

Cryptographic evidence trail

Every claim resolves to the primary record that supports it: source, retrieval timestamp, and content hash, anchored in a Merkle audit chain. Any finding can be independently verified against FDA's published data.

Verification

Designed to survive hostile verification.

Regulatory findings are only useful if they hold up under scrutiny — from your own quality team, from procurement, from counsel. Decision-OS is built so every claim can be checked, not trusted.

Each cited record carries its primary-source URL, retrieval timestamp, a content hash of the source document, and its position in a sealed Merkle audit chain. If a finding cannot be traced to a primary FDA record, it does not appear in the report.

evidence_id
d3e3d224-5ed7-5742-bede-c84997200dca
source
NSE/BSE regulatory filing — issuer-primary · National Stock Exchange of India archive
primary_url
https://nsearchives.nseindia.com/corporate/AUROPHARMA_23042025112317_LtrToSEsUSFDAapprovalEugia23042025.pdf
retrieved_at
2026-05-03T23:07:24Z
content_hash
ae0b52f90f06c4d26a4a6eff8c20c9bf841cf20521ed71eb83f76304eb448b1d
tree_id
f3e78f711bdd45139110c553bbf18efd  ·  leaf 38 / 59
Verify it yourself
Live fetch HTTP 200 · 476,108 bytes re-fetched from source
Hash match sha256(fetched) === content_hash, byte for byte
Merkle proof leaf 38 / 59 verifies against sealed root 9b6a0075…5d5daf63ba69

Open the URL, run sha256 on the returned PDF, and compare it to content_hash above — it matches, byte for byte. The document is a public filing in the National Stock Exchange of India archive.

Contact
Om Patel
Founder, Decision-OS