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Pricing · Inside the FDA Mind

Master FDA Regulations.
At Your Level. On Your Terms.

Three tiers, priced per regulation. You choose the regulation your operation lives under, and how far up the Five Levels you intend to go.

Every tier is sold two ways: a one-time purchase you keep, or an annual subscription that stays current as the regulation changes. Nothing here is a seat count dressed up as a plan - the tiers are depth of content, and they are cumulative.

Go straight to your industry

★All ProgramsPart 211Pharma / DrugsPart 820Medical DevicesPart 101Food LabelingPart 111SupplementsPart 117Food cGMPPart 11Electronic RecordsNDI · GRAS · FSVPNotificationsMoCRA · Part 700CosmeticsComing soonPart 1140Tobacco / NicotineComing soon
What Each Tier Unlocks

Tier by tier, tool by tool

The tiers map to the Five Levels of Regulatory Mastery, and they are cumulative - Proficiency includes Foundation, Mastery includes both.

Pay once, keep it - the version you buy, plus corrections to it

Asset
Foundation
Levels 1–2
Learn more →
Proficiency
Levels 1–4
Learn more →
Mastery
Levels 1–5
Learn more →
Full-length training video
Levels 1–2
Included
Full series
Full series
Companion handout
Levels 1–2
Included
Included
Included
Single module or complete series
Purchase scope
Either
Series only
Series only
Assessment exam
Graded, with answer key and rationale
Not included
Included
Included
Audit-ready SOP library
Level 3
Not included
Included
Included
SOP-linked forms
Level 3
Not included
Included
Included
Mock inspection checklist
Level 4
Not included
Included
Included
21Regulus AI access
Level 5
Not included
Not included
Included
Regulatory Snapshot Library
Reinforcement
View only
View only
Unlimited download
Updates and amendments
As the regulation changes
Annual only
Annual only
Annual only

Updates and amendments follow the purchase mode, not the tier: every annual subscription receives revised videos, handouts, SOPs, SOP-linked forms and checklists as the regulation changes. A one-time purchase receives corrections to the version bought. No tier includes consulting hours, and the Academy makes no accreditation or certification claim.

The Framework Behind the Tiers

The Five Levels of Regulatory Mastery

Judgment is acquired in order, one level at a time, and the order is not optional. The tiers exist because the levels do - each one is the set of tools that builds the next rung.

See the Five Levels in full →
  1. LEVEL 1Recite - what the regulation actually requiresFoundation
  2. LEVEL 2Understand - the reasoning underneath the ruleFoundation
  3. LEVEL 3Apply - knowledge lands on the floorProficiency
  4. LEVEL 4Anticipate - inspect your own house firstProficiency
  5. LEVEL 5Think Like the Inspector - judgment that works in real timeMastery
Choose Your Path

The Three Tiers, priced per regulation

Prices below reflect the one-time purchase selected above. Use the toggle to switch.

Showing:All programs

Foundation

LEVELS 1–2

One-time purchase · perpetual access to the version bought

The training video and the companion handout. You build command of what the regulation requires and the reasoning underneath it, section by section - the requirement in plain English, how an investigator evaluates you against it, the pitfalls, a real Warning Letter, and the fix.

  • Section-by-section video training
  • Written handout field reference
  • Buy a single module or the complete series
Start your road to mastery

Perpetual entitlement · corrections to the version bought

Regulation / Program
Modules
Per module
Complete series
21 CFR 111
Dietary Supplements
16
$199
$2,999
Choose
21 CFR 117
Food cGMP & Preventive Controls
23
$199
$4,250
Choose
21 CFR 101
Food & Supplement Labeling
41
$135
$5,250
Choose
21 CFR 211
Pharmaceuticals
11
$199
$1,999
Choose
21 CFR 820
Medical Devices - QMSR
15
$199
$2,750
Choose
21 CFR 11
Electronic Records & Signatures
Volumes I and II
2
$375
$750
Choose
FSVP
Foreign Supplier Verification Program
Preparation and submission
1
-
$735
Choose
GRAS
GRAS Notification
Preparation and submission
1
-
$735
Choose
NDI
New Ingredient Notification
Preparation and submission
1
-
$735
Choose

Every complete series prices below the sum of its individual modules - up to $327 saved versus buying module by module. Single-module purchase is available on every multi-module series, and is genuinely useful on Part 101, where labeling questions are section-specific.

Proficiency

LEVELS 1–4★ Most Popular

One-time purchase · perpetual access to the version bought

Everything in Foundation for the entire series, plus the graded assessment exam, the audit-ready SOP library, the SOP-linked forms, and the mock inspection checklist - the tools that put a system on the floor and let you inspect it yourself.

  • Everything in Foundation, full series
  • Assessment exam with answer key and rationale
  • Audit-ready SOP library, written per subpart
  • SOP-linked execution forms and mock inspection checklist
Build Your System

Perpetual entitlement · corrections to the version bought

Regulation / Program
Modules
Complete series
21 CFR 111
Dietary Supplements
16
$3,680
Choose
21 CFR 117
Food cGMP & Preventive Controls
23
$5,290
Choose
21 CFR 101
Food & Supplement Labeling
41
$9,430
Choose
21 CFR 211
Pharmaceuticals
11
$2,950
Choose
21 CFR 820
Medical Devices - QMSR
15
$3,450
Choose

Proficiency is sold at series scope only - an SOP library is meaningless for one subpart in isolation. Already hold Foundation for a series? You pay the difference, credited at checkout.

Mastery

LEVELS 1–5

One-time purchase · perpetual access to the version bought

Everything in Proficiency, plus 21Regulus AI - the Level 5 tool for the days nobody planned: a complaint that may be reportable, an investigator at reception, fifteen days running on a Warning Letter. The Regulatory Snapshot Library is included.

  • Everything in Proficiency
  • 21Regulus AI at the Unlimited level
  • Unlimited downloads of the Regulatory Snapshot Library - included
  • Twelve months of 21Regulus AI, then the Free plan
Get Full Command

Perpetual entitlement · corrections to the version bought

Regulation / Program
Modules
Complete series
21 CFR 111
Dietary Supplements
16
$4,230
Choose
21 CFR 117
Food cGMP & Preventive Controls
23
$6,085
Choose
21 CFR 101
Food & Supplement Labeling
41
$10,845
Choose
21 CFR 211
Pharmaceuticals
11
$3,390
Choose
21 CFR 820
Medical Devices - QMSR
15
$3,965
Choose

Mastery is Proficiency plus 15% for the same series. A one-time purchase cannot carry a perpetual service, so it includes twelve months of 21Regulus AI at Unlimited from the purchase date; after that the account falls back to the 21Regulus Free plan.

All prices are per seat, in USD. Upgrades are credited: buy Foundation for a series and move to Proficiency later, and you pay the difference. Orders above $2,500 can be placed by invoice with net terms - ask on the contact form. Multi-seat pricing is available for teams.

The Facility License · For Manufacturers

Not a tier. A different plan, for a different buyer.

The investigator will not ask whether your quality manager was trained. They will ask the person standing in front of them.

The operator on the packaging line, the warehouse lead who signs for incoming material, the second-shift supervisor who made a judgment call at 11 p.m. - those are the people an investigator stops, and those are the training files they pull. A license for five names in the quality office does not cover a single one of them. A Facility License covers everyone at your site for a year: no seats to assign, no headcount to track. The person you hire in March is covered the day they start.

Training and documentation

  • Unlimited users at the licensed site, including future hires, for the full term
  • The complete training series for the licensed regulation, in sequence
  • The full audit-ready SOP library and SOP-linked forms
  • The mock inspection checklist for site self-assessment

The training records pack - ready to use, ready to show

  • Training matrix - every module mapped to job function
  • Signed training sheets in the format an investigator expects to be handed
  • Self-assessment grading, with answer key and rationale retained alongside the score
  • Reporting by employee, department and module - including what is outstanding and overdue

Currency, and what comes with it

  • Continuous updates for the full term, with notification of exactly what changed
  • Regulatory Snapshot Library - unlimited download of the full poster set (licensed separately at $349 / year)
  • 21Regulus AI site-wide, with no user limit, on every Facility License

Two questions set your price

Which regulation, and how many people are at your site.

Band
Definition
Typical customer
Band A
Up to 25 employees at the licensed site
Small manufacturer, brand owner, single-line facility
Band B
26 to 100 employees at the licensed site
Growing manufacturer, contract manufacturer, multi-line site
Band C
101 or more employees at the licensed site
Established plant, multi-shift operation
Enterprise
More than one site, or corporate-wide
Contact us for multi-site licensing

Single-Regulation Facility License

Annual · unlimited users at one licensed site

Regulation series
Modules
Band A
Band B
Band C
21 CFR 111
Dietary Supplements
16
$4,750
$8,050
$12,800
Get a Quote
21 CFR 117
Food cGMP & Preventive Controls
23
$6,250
$10,600
$16,900
Get a Quote
21 CFR 101
Food & Supplement Labeling
41
$10,150
$17,250
$27,400
Get a Quote
21 CFR 211
Pharmaceuticals
11
$4,050
$6,900
$10,950
Get a Quote
21 CFR 820
Medical Devices - QMSR
15
$4,550
$7,750
$12,300
Get a Quote
All-Access
Every series, every submission module, and the full poster library
All
Priced by site and band
Get a quote today

Compare it honestly

Five Proficiency seats for Part 111: $5,080, one time - five named people, material frozen on the day you buy it. A Band A Facility License for Part 111: $4,750 per year - every person at your site, a complete training records pack, the full poster library, site-wide 21Regulus AI, revised every time the regulation moves.

Less money in year one - and it covers the people an investigator will actually stop and question.

And it does not go stale

On 2 February 2026, FDA retired the Quality System Inspection Technique and began inspecting device manufacturers under a different framework - six QMS areas in place of four subsystems, with the manufacturer’s own risk file as the roadmap. Every static package bought before that date now describes an inspection that no longer happens.

License Your FacilityTalk to us about multi-site

Employee count means total headcount at the licensed site, not quality department headcount. We do not audit it - we ask you to state it honestly.

Level 5 · Sold Separately Too

21Regulus AI

The Academy's own regulatory question-and-answer platform, built in house. Its knowledge base is verified against FDA-published source material, and every answer carries a citation.

Included with Mastery, and available on its own credit plans for anyone who wants the navigation system without the full roadmap.

Included with Mastery

Mastery annual subscribers receive 21Regulus AI at the Unlimited level for the life of the subscription. Mastery one-time buyers receive twelve months at Unlimited from the purchase date. When that access ends, the account falls back to the Free plan - never to nothing.

Free

50 credits / mo1 seatFree

Evaluation access across the whole of Title 21, with a complete citation on every response.

A free account is all it takes

Professional

600 credits / mo1 seat$39.95 / mo

The individual practitioner: plain-English interpretation, cross-Part comparison, and retained research.

$399.50 / year - twelve months at the cost of ten

Practice

1,800 credits / mo3 seats$69.95 / mo

Consultancies and departmental teams: document assessment against the controlling regulation, and formatted research output.

$699.50 / year - twelve months at the cost of ten

Unlimited

Unrestricted credits / mo1 seat$99.95 / mo

Unrestricted platform access for the professional working in Title 21 every day.

$999.50 / year - twelve months at the cost of ten

Start on the Free PlanA free account is required - 21Regulus AI is not open to anonymous visitors.

Annual subscription provides twelve months at the cost of ten. Credit allowances refresh monthly. Terms may be amended or discontinued at any time.

Continuous Reinforcement

Regulatory Snapshot Library

Single-page quick-reference posters - roughly 192 across 13 subject clusters today, expanding to around 310 as per-section posters are added for Parts 111, 101, 117, 820 and 211. Filed at a desk, posted on a wall, used as reinforcement between modules.

Anyone can browse and view the whole library. Downloading consumes a credit on the standard plan - Mastery includes unlimited downloads of the entire library at no additional cost.

Browse the Library

Standard plan

$39/ month

Monthly download credit allowance · one credit is one poster PDF

  • Browse and view the full library free - download requires credits
  • Cluster bundles and the complete library as one-time downloads
  • Watermarked PDFs delivered by time-limited signed link
  • Unlimited downloads included with every Mastery plan - no credits needed
Get Download Access
Pricing Questions

What buyers ask before they choose

Depth of content, not seat count. Foundation is the training video and the companion handout - Levels 1 and 2, available for a single module or a complete series. Proficiency covers Levels 1 through 4 - it adds the graded assessment exam, the audit-ready SOP library, the SOP-linked forms, and the mock inspection checklist, at series scope only. Mastery adds 21Regulus AI and the Regulatory Snapshot Library for Level 5. The tiers are cumulative.

The regulation isn't going anywhere.
Neither is the FDA.

Start free if you want to see the method work first: a free account opens the definitions library, the Warning Letter feed, MedWatch monitoring, a full sample lesson, and the 21Regulus AI free tier.

Start the 3-day trialBuild Your SystemGet Full Command

No card required. Free tools stay free.