Evidence
Establish what you can claim
Draft, vet, and prepare regulatory documents from controlled evidence, with every consequential claim traced to its source and tested for support.
Explore regulatory documentationRegulatory, evidence, and validation software
Licensed intelligence for life sciences.
Three products built to govern how evidence becomes permission to discover, claim, and validate.
Licensed intelligence is intelligence that has passed defined checks for evidence, provenance, consistency, and governance against the specific use proposed.
INDCSRBLANDA
IQ / OQ / PQ21 CFR Part 11Annex 11
Validate
Demonstrate fitness for use
Manage the equipment validation lifecycle from intended use and qualification planning through IQ, OQ, PQ, release, and requalification.
Explore equipment qualificationDiscovery
Advance what is worth pursuing
Move past model confidence toward scientific knowledge: explicit hypotheses, structured evidence, contradictions, warrant, and truth conditions.
Explore molecule intelligenceBiotok Evidence
Every claim earns its place.
Turn fragmented scientific, clinical, and regulatory sources into submission-ready content whose claims remain connected to inspectable evidence.
The language model may propose a claim. It cannot authorize its own claim.
Ingest the regulatory record
Bring protocols, study reports, analyses, publications, correspondence, and supporting records into a governed evidence environment.
Structure facts and claims
Extract entities, values, endpoints, populations, relationships, limitations, and contradictions while preserving source, page, and passage provenance.
Draft from controlled evidence
Develop sections for INDs, CSRs, BLAs, NDAs, briefing packages, responses, and related documents using the evidence available for that purpose.
Vet every consequential claim
Classify claims as supported, unsupported, conflicting, or uncited and expose the evidence and reasoning behind the determination.
Review and resolve
Direct regulatory, clinical, and scientific experts to gaps that require revision, additional evidence, qualification, or accountable judgment.
Prepare for submission
Finalize traceable content with visible provenance, review history, and a defensible record of what the available evidence permits the organization to say.
Biotok Validate
Validation intelligence across the equipment lifecycle.
Connect intended use, requirements, risk, specifications, protocols, execution evidence, deviations, and approvals into a validation record that remains current throughout the equipment lifecycle.
Validate does more than digitize IQ/OQ/PQ. It evaluates whether the accumulated package supports a defensible conclusion of fitness for intended use.
Built for records that must satisfy 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity expectations.
DefineIntended use, URS, specifications, critical requirements
AssessRisk analysis, FMEA, qualification strategy, coverage
QualifyIQ, OQ, PQ protocols, execution, results, evidence
ReleaseDeviation resolution, approvals, readiness, validated state
OperateCalibration, maintenance, monitoring, periodic review
ChangeImpact assessment, change control, targeted testing
RequalifyTrigger-based and periodic requalification
RetireControlled decommissioning and retained evidence
Architecture
AI can propose.
Evidence must permit.
General-purpose AI can produce fluent language even when the evidence is incomplete. Biotok products separate generative capability from evidentiary authority.
WorldMind's licensing architecture determines whether a claim, hypothesis, or validation conclusion has met defined conditions for its intended use.
Biotok products are grounded in first-principles research from the WorldMind AI Research Lab. We use large language models as language engines rather than authorities on knowledge or truth, while WorldMind's architecture provides the evidence, reasoning, and governance needed for dependable intelligence.
Sources become inspectable claims, facts, requirements, risks, tests, and relationships, not merely text retrieved for a chatbot.
Evidence is evaluated for provenance, applicability, consistency, completeness, and the precise use being proposed.
Supported work can progress. Insufficient or conflicting work is qualified, blocked, or routed for accountable human review.
Coming soon
Biotok Discovery
Beyond coherence toward knowledge.
WorldMind is building AI from first principles rather than assuming that a large language model is itself a cognitive engine.
Language is not cognition
A model's confidence is not a reason to fund a program. An LLM is an extraordinary linguistic proposal engine, and its coherent output does not, by itself, establish knowledge, reference, warrant, or truth.
Knowledge needs structure
Discovery will represent hypotheses, entities, relationships, experimental evidence, provenance, conflicts, and uncertainty outside the model.
Truth has conditions
A candidate proposition must be evaluated against explicit conditions under which it would be supported, contradicted, limited, or unresolved.
Progress requires permission
The surrounding architecture, not the model's confidence, governs whether a hypothesis or candidate is sufficiently warranted to advance.
Discovery does not promise an oracle of scientific truth.
It is designed to make the conditions, evidence, conflicts, and warrant for scientific propositions explicit—so researchers can investigate what is promising without mistaking plausibility for knowledge.
Built by WorldMind
Commercial life-sciences software grounded in AI research.
Biotok is the life-sciences software of WorldMind Inc., an AI research laboratory developing architectures for structured, verifiable, and governed intelligence.
WorldMind's research on language models and knowledge has been published in Minds and Machines.
Contact WorldMindSee licensed intelligence at work.
Bring one submission bottleneck or one qualification package. We will show you what the evidence permits you to say.
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