Regulatory Content Infrastructure

Regulatory content you can prove. Every time.

BubbaBooie is the audit-ready source of truth for drug labels, packaging, and patient information — built for pharma and biotech teams who can't afford the risk of Word files.

FDA 21 CFR Part 11GxP ReadySOC 2 Type II

Trusted by teams in:

Regulatory AffairsMedical WritingLabeling & ArtworkCMC / CDMOPharma Compliance

The numbers that matter

Audit-ready in minutes, not weeks

< 5 minAudit export timeWas: weeks of manual effort
$0K+Average savings vs enterprise suitePer year
0%Version-controlled approved wordingAlways
0Regulatory non-conformances from label driftZero tolerance, enforced
21 CFR Part 11 CompliantElectronic records & signatures
Immutable Audit TrailTamper-evident change log
GxP ValidatedValidation documentation included
Role-Based AccessApproval workflows built in

Built for inspection day

One source. Zero surprises.

Step 1

Capture Approved Wording

Store every approved phrase, sentence, and section in a single canonical library. No more 17 Word files across 3 shared drives.

Step 2

Generate Deterministic Outputs

The same approved text always produces the same label output — no drift, no &apos;which version did we use?&apos; every submission cycle.

Step 3

Export Complete Provenance

When a regulator asks, produce a timestamped chain of custody — who approved it, when, under what authority — in under 5 minutes.

“When an inspector asks for the approved version of a label at a specific point in time, BubbaBooie produces it instantly, with a complete chain of custody.”
Everything a labeling team needs

No more heroic manual effort

black pen on white printer paper

Canonical Wording Library

One place for every approved phrase. Your label language lives here, versioned and locked.

Immutable Change Log

Every edit is timestamped with the editor's identity, reason, and the version it replaced. Regulators love it.

Multi-Market Variants

Manage EN/DE/FR label variants without duplicating approved wording. One canonical block, many markets.

Role-Based Approvals

Medical writers draft. Regulatory leads approve. No step is skippable.

Deterministic Output

The same approved text always produces the same artifact. No drift, ever.

One-Click Audit Export

Complete chain of custody, timestamped and attributed, in under 5 minutes.

Stop choosing between overkill and under-build

The right tool for mid-market pharma

FeatureBubbaBooieBest fitVeeva VaultSharePoint / Word
Audit-ready provenanceAutomaticManual setupNone
Implementation timeDays3–6 monthsWeeks of customization
Annual cost$15K–$40K$100K+Hidden IT costs
Purpose-built for labelingYesBroad QMSNo
Canonical approved wordingCore featureConfigurableNo
Deterministic outputsBuilt-inAdd-onNo
Mid-market team fitYesEnterprise onlyGeneric
Right-sized for mid-market pharma

Transparent pricing. No surprises.

Starts well below six figures. Scales with your product portfolio.

Starter

$1,250/mo

Best for: 1 product, 1–2 markets

  • 1 product label library
  • Up to 2 market variants
  • 5 user seats (3 roles)
  • Immutable change log
  • One-click audit export
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Most Popular

Professional

$2,500/mo

Best for: 5 products, multiple markets

  • 5 product label libraries
  • Up to 10 market variants
  • 15 user seats
  • Full audit provenance reports
  • Change control workflows
  • Priority support
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Team

$3,750/mo

Best for: 10+ products, enterprise-adjacent teams

  • Unlimited product libraries
  • Unlimited market variants
  • 40 user seats
  • Custom approval workflows
  • Dedicated onboarding
  • SLA support
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Annual billing available — save 20%

From the teams who've lived the audit scramble

The last FDA inspection cost us three weeks reconstructing approval history from email threads. With BubbaBooie, that export takes four minutes.

Director of Regulatory Affairs, Specialty Pharma

We replaced 17 Word documents across 3 shared drives with one canonical source. Our medical writers spend less time hunting for the right version and more time writing.

Head of Medical Writing, Biotech

The question from our inspector was ‘show me who approved version 2.3 of the patient leaflet and when.’ We had the answer in the time it took them to finish asking.

VP Regulatory Affairs, CDMO

Testimonials are illustrative composites based on common regulatory team experiences and do not represent named individuals.

Frequently asked questions

Stop reconstructing approvals. Start proving them.

Join the pharma and biotech teams who've made audit day the easiest day of the year.

No implementation project. Live in days.

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