A regulatory intelligence platform constructed from one source: Title 21.
Drugs: General | Drugs for Human Use | Animal Drugs | Biologics | Cosmetics | Medical Devices | Mammography Quality Standards Act | Radiological Health | Tobacco Products
- Title 21, Parts 1-1299
- Subchapters A through L
- Section-level citation on every response
- Verified against the government source
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.
Accuracy is a property of method, not of assertion.
Any platform may claim accuracy. The question a regulatory professional asks is a different one: by what method is that accuracy established, and by what means may it be independently confirmed?
- Attributable
- Every response identifies the Part, Subpart, and Section from which it derives. No content is returned without an attributable origin within Chapter I.
- Legible
- The promulgated text is presented as promulgated. Where interpretation is furnished, it is distinguished from the regulatory language rather than blended into it.
- Contemporaneous
- Content is monitored against the official source and updated as amendments are published. Each response indicates the currency of the text upon which it relies.
- Original
- The corpus derives from the regulation itself rather than from secondary treatment of it. The platform reports the source, not a report of the source.
- Accurate
- Verification against FDA.gov precedes incorporation, without exception, and performance against a documented acceptance benchmark is recorded prior to release.
These are the attributes your data integrity programme already requires of every record you retain. We saw no reason a regulatory reference should be held to a lesser standard.
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.
The whole of Title 21, Chapter I.
Regulated organisations rarely operate within a single Subchapter. A combination product raises questions under Subchapter H and Subchapter C simultaneously. A contract manufacturer may hold obligations under Parts 210 and 211, Part 820, and Part 117 within a single facility. The platform was accordingly built to the full extent of Chapter I, so that a question may be pursued wherever the regulation takes it - and answered to the same verified standard in every Part.
| Subchapter | Parts | Scope |
|---|---|---|
| Subchapter A1 - 99 | 1 - 99 | General |
| Subchapter B100 - 199 | 100 - 199 | Food for Human Consumption |
| Subchapter C200 - 299 | 200 - 299 | Drugs: General |
| Subchapter D300 - 499 | 300 - 499 | Drugs for Human Use |
| Subchapter E500 - 599 | 500 - 599 | Animal Drugs, Feeds, and Related Products |
| Subchapter F600 - 680 | 600 - 680 | Biologics |
| Subchapter G700 - 799 | 700 - 799 | Cosmetics |
| Subchapter H800 - 898 | 800 - 898 | Medical Devices |
| Subchapter I900 | 900 | Mammography Quality Standards Act |
| Subchapter J1000 - 1040 | 1000 - 1040 | Radiological Health |
| Subchapter K1100 - 1150 | 1100 - 1150 | Tobacco Products |
| Subchapter L1210 - 1299 | 1210 - 1299 | Regulations Under Certain Other Acts Administered by the FDA |
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
Requirement and implementation, addressed together.
21 Regulus AI is connected to TheCGMPAcademy, our FDA compliance e-learning library published under the Inside the FDA Mind imprint.
The platform identifies what the regulation requires. The Academy addresses how that requirement is satisfied within a functioning quality system - the procedures, records, and controls that constitute compliance in practice rather than on paper. Questions arising from the instruction return to the platform, which returns them to the regulation.
Explore the Resources libraryOne corpus. Four levels of use.
- Free
$0/mo
No card required
Evaluation access to the whole of Title 21, at no cost. 25 credits monthly, every feature, no card required. Add seats at $20 each per month.
- Standard
$39.95/mo
or $399.50/yr - twelve months at the cost of ten
The individual practitioner. 600 credits monthly per seat, plain-English interpretation, cross-Part comparison, and retained research. Add seats at $20 each per month.
- Advanced
$69.95/mo
or $699.50/yr - twelve months at the cost of ten
Consultancies and departmental teams. 1,800 credits monthly per seat, document assessment against the controlling regulation, and the whole of Title 21. Add seats at $20 each per month.
- Unlimited
$99.95/mo
or $999.50/yr - twelve months at the cost of ten
Unrestricted platform access for the professional engaged with Title 21 daily. Add seats at $20 each per month.
One credit is one answered question. A question the verification gate declines to answer costs nothing. Every plan reaches the whole of Title 21 and every feature - only the allowance differs. Each plan includes one seat; additional seats are $20 each per month on every plan. A credit allowance is granted monthly, and unused credits carry forward. Annual subscription provides twelve months at the cost of ten. Terms may be amended or discontinued at any point.
Full Commercial TermsAudit 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.
Choose a Plan and Begin