Claims arrive without the full decision context.
Source evidence, analysis methods, assumptions, limitations, versions, reviewers, and decision rationale are frequently separated from the statement that enters the submission.
Regulatory & submission intelligence
Build submissions from governed evidence.
StromaOS connects regulatory strategy, health authority questions, claims, source evidence, analyses, medical writing, review, commitments, approvals, and submission execution in one traceable operating environment.
Evidence-bound claims
Governed content reuse
Separated approval authority
Traceable submission execution
The regulatory operating problem
Regulatory output is assembled after the evidence chain has already fragmented.
Regulatory teams often receive analyses, conclusions, tables, narratives, and proposed claims after the operating context that produced them has been separated across functions, vendors, documents, systems, and review cycles.
Teams repeatedly recreate approved knowledge.
Writers, reviewers, affiliates, and vendors copy and adapt content across documents without a shared governed evidence object or explicit reuse boundary.
Comments are resolved without preserving the decision chain.
Review cycles capture edits but often lose the underlying issue, evidence conflict, decision authority, rationale, and downstream effect of the resolution.
Drafting can accelerate faster than approval governance.
AI can summarize, compare, draft, and reuse content, but it cannot be allowed to collapse evidence selection, scientific interpretation, regulatory judgment, approval, and release into one step.
How the solution works
Regulatory work becomes one governed strategy-to-submission chain.
StromaOS coordinates requirements, evidence, claims, authoring, review, approval, commitments, health authority response, and submission records in one execution model.
STEP 01
Define the regulatory objective
Strategy, meeting, question, submission, variation, response, label, commitment, or market requirement.
STEP 02
Assemble the evidence basis
Clinical, safety, CMC, MIDD, RWE, HEOR, literature, precedents, guidance, and prior decisions.
STEP 03
Bind claims to evidence
Approved analyses, conclusions, limitations, confidence, jurisdiction, permitted use, and evidence status.
STEP 04
Author and review
Draft from approved evidence, reuse governed content, preserve citations, route comments, conflicts, and decisions.
STEP 05
Approve and release
Technical, medical, regulatory, quality, publishing, submission, and market-specific authorization.
STEP 06
Preserve and respond
Versions, evidence, rationale, approvals, commitments, authority questions, responses, outcomes, and lessons.
Claim and content control
A claim should never be separated from the evidence and authority behind it.
StromaOS treats claims as governed evidence objects rather than sentences copied between documents. Each claim retains the approved evidence, analysis, limitations, confidence, jurisdiction, audience, permitted use, owner, status, and required approval.
Content can be reused faster because the boundaries of reuse are explicit.
Model a claim workflow
Claims stay tied to the evidence that supports them. The lineage from source to submitted statement is the deliverable, not a document produced alongside it.
Governance throughout regulatory execution
AI can accelerate authoring without inheriting approval or release authority.
StromaOS separates retrieval, analysis, interpretation, claim formation, drafting, technical review, medical review, regulatory review, approval, publishing, submission, and release.
Explore the Governance Spine01
Claim governance
Every regulated statement remains connected to approved evidence, analyses, limitations, confidence, jurisdiction, permitted use, owner, review state, and version.
02
Content reuse governance
Approved components can be reused within explicit boundaries. Local adaptation, audience, market, document type, and required re-review are governed.
03
Separated authority
Drafting, scientific review, regulatory review, quality approval, publishing, submission, and release remain distinct permissions assigned to accountable roles.
04
Review and conflict control
Comments, evidence conflicts, proposed changes, rationale, decisions, owners, and downstream effects remain part of the execution record.
05
Evidence Data Trace
Sources, transformations, analyses, prompts, methods, versions, comments, decisions, approvals, commitments, submissions, and responses remain reconstructable.
Start with one submission, response, claim workflow, or review bottleneck.
Connect the evidence sources and specialist systems already in use. Define the claim standard, review sequence, approval authority, quality gates, content reuse boundaries, and release controls. Then run the work as one governed regulatory operation.