INTELLIGENCE · KNOWLEDGE GRAPHSYNTHETIC DATARA LEAD · DRUG
Regulatory Knowledge Graph
The connective tissue between products, markets, requirements, documents and past deficiencies.
PRODUCTS
147
Molecule, strength, form, manufacturer
MARKETS
38
With at least one live registration
DOCUMENTS
12,480
Versioned, section-classified
REQUIREMENTS
2,914
Extracted from released templates
DEFICIENCIES
611
Indexed by market and section
SITES
22
Own plants and contract manufacturers
GRAPHRAG · GROUNDED RETRIEVAL
Graph Explorer
Products, markets, suppliers, requirements, documents and deficiencies as one connected object. Click a node to inspect it; every answer AImate gives is retrieved from these edges.
CENTRE ON
PRSolufexin 0.4 mg MR● CENTRE
MKVietnam NRA→ REGISTERED_IN
MKPhilippines NRA→ FILED_IN
SPNorvexa→ API_FROM
SPKaviro→ API_FROM
SPSintell→ API_PENDING
DOStability study SLX-ST-04→ STABILITY_BY
RQRaw batch data rule→ MUST_SATISFY
DFRound 2 · item 4→ QUERIED_ON
DOVN-4417-26→ LICENCED_AS
RQPack split rule→ SPLIT_BY
DFDMF never received→ BLOCKS
RQPH-GEN-NEW r7→ GOVERNED_BY
DFZone 4B gap→ GAP_IN
14 NODES · 13 EDGES · ALL TYPES · SYNTHETIC
CENTRE NODE
PRSolufexin 0.4 mg MRPRODUCT
The portfolio’s three-supplier product, and that single fact drives its whole regulatory shape. Because section 3.2.S replicates per approved API supplier, every market dossier carries the drug-substance block three times — and the one supplier who never sent a DMF blocks all of them at once.
MASTER VERv6 · 318 documents
MARKETS2 approved, 4 in registration
OPEN QUERIES3 across 2 markets
OPEN RISKSSintell DMF, Zone 4B stability
EDGES FROM HERE
REGISTERED_INVietnam NRA
FILED_INPhilippines NRA
API_FROMNorvexa
API_FROMKaviro
API_PENDINGSintell
STABILITY_BYStability study SLX-ST-04
MUST_SATISFYRaw batch data rule
QUERIED_ONRound 2 · item 4
Governed Knowledge Graph
The connective tissue between ideas, products, markets, requirements, documents, sites and past deficiencies. Grounded, not guessed — and it grows with every dossier Mega lands.
SELECTED ENTITY
Provastide + Solufexin 0.5/0.4 mg
Provastide softgel capsule plus solufexin pellets in a hard capsule. Outsourced, bioequivalence run by a CRO. Identity is bound to molecule, strength, dosage form and manufacturer.
REGISTERED INVietnam · Philippines · Peru · Ethiopia
MASTER DOSSIERCTD v4.2 — 318 documents
SUPPLIED BYContract development partner
HAS ACTIVITYNew registration x3, variation x1
Traced Answer
“Which Vietnam documents depend on the Zone 4B stability study?”
QUESTION
Which Vietnam documents depend on the Zone 4B stability study?
REQUIREMENT
Zone 4B stability data — demanded by Vietnam, Philippines, Indonesia.
DOCUMENTS
Study report SR-4B-118 and four sections in module 3.2.P.8.
CONSEQUENCE
Two compilation runs held; supplier countersign outstanding eight days.
Inferences Drawn This Week
Links the graph made that nobody entered by hand. Each one is a question the team would otherwise have found out late.
Zone 4B gap will block four markets, not oneHIGH
One stability study is cited by seven registrations across four markets that all require zone 4B.
Raised on the Solufexin gap list — 12 Aug
Sintell DMF blocks two products, not oneHIGH
The same supplier block is replicated in Solufexin and Provastide masters.
Supplier escalation opened — 09 Aug
Philippines checklist change reaches one live runHIGH
Template r7 touches II · P.3, which the Zenaflozin run has already mapped.
Run flagged, awaiting r7 release
Round-2 chromatogram questions cluster on one methodMEDIUM
Nine of eleven chromatogram queries in three years cite the same analytical procedure.
Added to audit pre-empt list
Artwork is the most common launch blockerMEDIUM
Certification wait appears on the critical path in six of the last nine launches.
Surfaced on the launch dashboard
Grounding Coverage
Where the graph can answer with an approved source, and where it will refuse. The refusals are published, not hidden.
Dossier content and versions96%
Answers cite a document version or refuse.
Market requirements88%
Only released template revisions are readable.
Deficiency history74%
Pre-2019 queries were never captured in a system.
Supplier documentation62%
Closed DMF parts stay with the supplier by agreement.
Commercial forecasts41%
Held outside the platform; the graph will not infer them.
Email and chat decisions0%
Not ingested. If it was decided in email, the graph says so.
SYNTHETIC DATAAll data on this page is synthetic. Product names, brands, people, project numbers, suppliers, authorities, dates and figures were generated for demonstration and represent no real product, person, filing, supplier or company record. Structure and rules illustrate how the platform behaves, not any actual submission.