Cross-region pharma GMP inspection corpus

Name: Cross-region pharma GMP inspection corpus: 58,691 normalized records spanning FDA Form 483 observations (16,412), EMA EudraGMDP GMP/Non-GMP certificates and non-compliance deficiency reports (18,791), MHRA GMDP outcomes (1,717) and Health Canada records (21,771), enriched with AI plain-language summaries of every observation, cGMP-system classification, FEI/establishment linkage and investigator-level 'strictness' profiles.
Creator: Ipharmaai

IPHARMAAIManage supplier listing

Cross-region pharma GMP inspection corpus: 58,691 normalized records spanning FDA Form 483 observations (16,412), EMA EudraGMDP GMP/Non-GMP certificates and non-compliance deficiency reports (18,791), MHRA GMDP outcomes (1,717) and Health Canada records (21,771), enriched with AI plain-language summaries of every observation, cGMP-system classification, FEI/establishment linkage and investigator-level 'strictness' profiles.

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Coverage

Universe, instruments and categories.

Industry: PharmaceuticalsApplication Software
Instruments: equities
Categories: Alternative

Dataset card

Type: not stated
Format: Multimodal — structured tabular records plus full original inspection text, downloadable certificates/deficiency report documents, and derived summary/classification text.
Volume: 58,691 inspection records (16,412 FDA 483 observations + 18,791 EudraGMDP + 1,717 MHRA + 21,771 Health Canada), each with full original text plus a generated summary — plus 600-question cGMP checklist corpus and investigator profile records.
Users: No registered-user figure published; institutional subscription client base — plausibly low hundreds of regulatory-affairs seats, inferred from a founder-led early-stage SaaS carrying 4 agency datasets.
History: 20 years
Update frequency: not stated
Growth: Active — 4 regulatory regions and 58,691 records assembled, AI-summary layer added recently, founder actively marketing the platform via 2025 webinars; still single-founder-led with no disclosed enterprise client roster.
Launched: ~2024-2025 (platform marketing and webinar promotion in 2025; founder's prior regulatory-services venture founded 2023, so the AI inspection database is a later product of the same founder).
Delivery: not stated
Entity mapping: not stated
Sample: not stated
Point-in-time: not stated
Licence: not stated

supplier index read from their site