One source. All of 21 CFR.
21 Regulus AI is built on one source: the text of Title 21. Every Part, from 1 through 1299 - food, drugs, biologics, cosmetics, medical devices, radiological health, tobacco - is verified against FDA.gov.
Regulated industry depends on accurate, verified information.
21 Regulus AI is built on one source: the text of Title 21. Every Part, from 1 through 1299 - food, drugs, biologics, cosmetics, medical devices, radiological health, tobacco - is verified against FDA.gov.
The platform is also built to know where the regulation ends. When a subject is not addressed in Title 21, 21 Regulus AI says so plainly rather than filling the gap with something that sounds authoritative.
This is the difference between a general-purpose AI tool and a controlled one. General tools draw from the whole internet and produce fluent answers whether or not the underlying source is sound. 21 Regulus AI draws from one source, verified, with the citation attached to every answer.
One source. All of 21 CFR.
Verification and validation are not features of this platform. They are its architecture.
The discipline is familiar: verification confirms the system was built correctly; validation confirms it performs its intended function. We applied that framework to the construction of the platform itself, and we document it because we expect to be asked.
- I
Controlled sourcing
The platform derives from the promulgated text of Title 21 of the Code of Federal Regulations, Chapter I, Parts 1 through 1299. Not aggregated secondary commentary. Not consultancy interpretation. Not scraped web content of indeterminate provenance. The regulation, as published.
- II
Verification against the government source
No regulatory content is incorporated into the platform until it has been verified against FDA.gov. Where any secondary source conflicts with the official text, the official text governs. This is applied without exception, and it is the reason the tagline reads as it does.
- III
Section-level traceability
Every response identifies the Part, Subpart, and Section from which it derives, accompanied by a direct link to the controlling text. The platform does not ask for your confidence. It supplies the means to audit it - which is the only form of assurance that carries weight in this industry.
- IV
Documented acceptance testing
Prior to release, the platform is assessed against a formal acceptance benchmark: a fixed battery of regulatory questions spanning every Subchapter, scored for citation accuracy and substantive correctness. Successful completion is a contractual gate on the build. Performance is recorded, not asserted.
Where an answer cannot be traced to its source, the platform does not provide the answer.
Who the platform is built for
- Regulatory affairs professionals preparing submissions, notifications, applications, and agency correspondence in which every citation is subject to review
- Quality assurance and quality systems leadership drafting procedures, quality manuals, and policies that must trace to a controlling requirement
- Food safety and technical directors developing food safety plans, hazard analyses, and preventive control programmes
- Product development, formulation, and labelling teams establishing what a claim, an ingredient declaration, or a specification obliges before a product reaches market
- Consultants and contract regulatory practices operating across multiple sectors and client quality systems
- Internal audit and supplier qualification functions constructing audit programmes and questionnaires traceable to the regulation
- Emerging manufacturers and brand owners across every regulated category, operating without a fully established regulatory department
- Executive and operational leadership requiring an accurate understanding of an obligation without reading the whole of a Part to locate it
- Training and compliance educators delivering instruction in cGMP, HACCP, quality systems, and design controls
Audit the platform before you adopt it.
Put to 21 Regulus AI a question to which you already know the answer, in an area in which you have practised for years. Follow the citation to the official text. Confirm the response against the source. This is the standard to which the platform was constructed, and the only demonstration that carries weight with a professional audience.
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