PLAYBOOK · LIFE SCIENCES
A regulatory submission assistant built on Living Knowledge.
Regulatory submissions stitch together CMC, clinical, non-clinical, and labeling content. This playbook puts every document into a Living Knowledge graph and lets specialist agents draft and validate each module against agency guidance — all without sending data outside.
The problem
Submissions are knowledge graphs in disguise
An eCTD module references batches, studies, methods, and labels. Authoring teams reassemble that web by hand every cycle.
The VDF AI approach
One Living Knowledge graph, many specialists
Indexed documents, extracted entities, and relationships sit in a graph. Specialist agents draft each module; a validator checks consistency. Authoring leads review and approve.
REFERENCE ARCHITECTURE
Graph in, draft modules out
Entities · Relationships · Vectors
Intent: draft-module
PLAYBOOK · STEP BY STEP
From document pile to draft submission
Ingest CMC, clinical, and labeling content
VDF Data extracts entities (batches, studies, methods, products) and relationships into the knowledge graph alongside the vector index.
Define specialist agents
Each specialist owns a sub-area of the submission and follows a strict outline aligned to agency templates.
Wire validation loops
A Consistency Validator checks batch numbers, study identifiers, and dosing across drafted sections, flagging mismatches before the authoring lead sees them.
Author and approve in the Portal
Each drafted section ships with citations to the source documents and to the agency guidance it satisfies.
Operate under audit
Live Execution Monitoring stores every decision. SEEMR routes heavy reasoning to your high-capability private model.
OUTCOMES
Submission cycles compress, quality holds
authoring cycle time per module.
cross-section consistency issues caught pre-review.
proprietary CMC or clinical content leaves the perimeter.
SEEMR REFERENCE
The graph keeps learning across cycles
SEEMR's Knowledge Graph mode incorporates every approved section as a future retrieval signal. Subsequent submissions start with stronger context.
GET IN TOUCH
You Have Questions
Tell us what you’re trying to achieve—governed AI Networks, enterprise RAG, deep integrations, or on‑premise deployment. We’ll help you map the right architecture, security posture, and rollout path. If you’re moving beyond AI pilots and need scalable, auditable execution, reach out—our team is ready to help.