Coverage
The regulatory corpus Preclari draws on: every source currently onboarded, every source being added next, and the directions we will extend into as customer engagements require. If your jurisdiction or domain isn't listed here, we will onboard it for your engagement. Public jurisdiction additions enter the shared corpus snapshot once onboarded. Your workflow data does not — see retention for what's stored and for how long.
Curated. Every source hand-reviewed. No crawling.
Onboarded
in the corpus todayPlanned next
active onboardingSwissmedic guidance on computerised systems in GMP
Unlocks: Swiss manufacturing AI workflows; aligns Preclari output with Swiss inspection expectations under PIC/S Annex 11
Roadmap — sources & documents
ordered by demand signalICH Q7 — Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Unlocks: API manufacturing AI workflows (deviation, OOS, change control)
FDA Draft Guidance — Considerations for the Use of Artificial Intelligence and Machine Learning in Drug Manufacturing AI-specific context
Unlocks: AI-specific GMP context for US workflows
EMA Reflection Paper on the Use of Artificial Intelligence in the Lifecycle of Medicinal Products AI-specific context
Unlocks: AI-specific EU context across the medicinal product lifecycle
Roadmap — jurisdictions & domains
onboarded for your engagementJapan — PMDA
Prioritised as the first non-EU/US jurisdiction; many global pharma AI projects expand JP after EU+US.
Pharmaceuticals and Medical Devices Agency guidance not yet onboarded; translation and structural alignment required.
We onboard for: Your workflow touches Japanese market authorisations or PMDA-inspected sites.
China — NMPA
National Medical Products Administration guidance not yet onboarded; corpus requires NMPA-specific document curation.
We onboard for: Your workflow operates in or imports to mainland China and is regulated by NMPA.
India — CDSCO
Central Drugs Standard Control Organisation guidance not yet onboarded.
We onboard for: Your workflow involves CDSCO-regulated manufacturing or distribution.
Brazil — ANVISA
Agência Nacional de Vigilância Sanitária guidance not yet onboarded.
We onboard for: Your workflow operates under ANVISA jurisdiction.
Korea — MFDS
Ministry of Food and Drug Safety guidance not yet onboarded.
We onboard for: Your workflow involves Korean market authorisation or MFDS-inspected sites.
GCP and GLP
The first v0.1 wedge is GMP-adjacent workflows. Clinical (GCP) and laboratory (GLP) preflight require their own corpus and reasoning patterns and are deferred to a later release.
We onboard for: Your workflow is clinical-research-facing (GCP) or non-clinical laboratory (GLP).
Veterinary medicines
Veterinary GMP and EMA/CVMP veterinary medicines guidance are not yet onboarded. They differ enough from human-pharma GMP to warrant a separate corpus.
We onboard for: Your workflow is veterinary-pharma rather than human-pharma.
Switzerland — IvDV (In-vitro-Diagnostika-Verordnung, SR 812.219)
Swiss IVD ordinance (Switzerland's parallel to EU IVDR 2017/746) not yet onboarded. MepV (Swiss MDR parallel, SR 812.213) is covered. IvDV requires separate extraction under the same verbatim gate.
We onboard for: Your workflow involves Swiss in-vitro diagnostic devices regulated under IvDV.
IMDRF — MDSAP audit criteria
Medical Device Single Audit Program (MDSAP) audit approach and task descriptions (IMDRF/MDSAP WG/N9 and related documents) not yet extracted. The imdrf-samd-mdsap corpus entry covers SaMD frameworks only. MDSAP covers manufacturers in AU/BR/CA/JP/US.
We onboard for: Your workflow involves MDSAP audit readiness or single-audit participation.
Need a jurisdiction or domain not yet on this page?
Onboarding is driven by real engagements. If your workflow touches a jurisdiction, regulator, or GxP domain that isn't visible here yet,