Complyfda

ComplyFDA (ComplyFDA LLC) — Proprietary structured database of FDA Form 483 observations and enforcement activity from 2017 to present, indexed by 21 CFR Part 211 (pharma) and Part 820 (device) subpart and regulation, with live eCFR cross-links, plus a 483Pulse trend-visualization layer, a quarterly SENTINEL quality-system risk assessment scoring series, and an Insider Intelligence/discussion corpus.. Micro-scale specialist vendor (3 employees, New Jersey) holding a nationally-scoped proprietary asset: 9 years of fully indexed FDA 483 observations mapped regulation-by-regulation across both d…

Complyfda offers (Alternative, Supply Chain, Fundamental) — est. 50K-120K normalized observation rows spanning 2017-present across both Part 211 and Part 820 subparts (FDA issues on the order of 10K+ Form 483s per year carrying multiple observations each; the vendor claims comprehensive activity across both programs).

GMP inspection-readiness benchmarking by regulation subpart; contract-manufacturer and supplier qualification; pharma/device equity research on quality-failure risk; internal management-review evidence packs; ML training on observation classification and repeat-citation prediction; regulatory affairs trend dashboards.

The data is with 9 years of history.

Coverage spans US, UK; Pharmaceuticals; alternative, supply_chain, fundamental; equities.