For Health Canada-Regulated NHP Manufacturers

When the inspector asks for your stability data, what do you hand them?

StabilityForge is the operating system for your NHP stability program — auto-numbered protocols, time-point reports, and expiry justification, all version-controlled and aligned to ICH Q1A(R2) and Health Canada NHPD standards. Built for the moment the audit begins.

ICH Q1A(R2) aligned Health Canada NHPD NHPR §44–46
Aligned ToICH Q1A(R2)
AuthorityHealth Canada NHPD
RegulationNHPR · SOR/2003-196
Climate ZoneZone II · Canadian Market
MethodsUSP · ICH Q2(R1)
Three Audit Scenarios

The questions most NHP companies cannot answer in 90 seconds.

These aren't hypothetical. They are the actual questions Health Canada inspectors are asking. The companies losing are not the ones with bad data — they're the ones with scattered data.

Scenario 1 · Site Inspection
Show me the most recent time-point report for NPN 80012345 and the version-controlled protocol it was tested against.
What happensEmail archaeology starts. Two QA staff lose 4 hours. The inspector documents the delay. Finding written.
Scenario 2 · NHPD Submission
Justify the 24-month expiry claim with stability data showing all attributes within specification through T = 24 months.
What happensThe submission stalls. Reviewer requests are sent. Six weeks lost rebuilding documentation. Launch slips by a quarter.
Scenario 3 · Staff Departure
The stability coordinator just resigned. Where is the current state of the program?
What happensThe replacement spends 60 days reconstructing what one person held in their head. Two product launches go on hold. Audit exposure climbs.
The StabilityForge System

Four documents. One controlled chain.

Health Canada will eventually ask to see four documents in this exact order: the protocol, the time-point reports, the pass/fail evaluation, and the expiry justification. StabilityForge connects them into a single auto-numbered, version-controlled workspace where the audit trail is the byproduct of doing the work — not a separate task.

01

Project

Auto-coded workspace per product or product line. Every document inherits the project number.

02

Protocol

ICH-compliant study design. Auto-numbered, version-controlled. References inline.

03

Report

Time-point results per batch. Pass/fail auto-evaluated against the protocol's spec.

04

Conclusion

Expiry justification generated from results. Citations attached. Sign-off ready.

=
OUTPUT

Audit-Ready

Inspector asks the question. You answer in 90 seconds. Every time.

What You Replace

  • Word protocol drafts on a shared drive
  • Excel result trackers — one per analyst, none current
  • Pass/fail decided by the QA manager at 4pm Friday
  • Expiry justification rebuilt during submission week
  • Audit prep that takes two weeks of overtime
  • One coordinator holding it all in their head

What You Get

  • Auto-numbered protocols under a project code
  • Time-point reports linked to the source protocol
  • Auto-evaluated against the protocol's acceptance criteria
  • Generated at every time point, ready to attach
  • Audit prep that is the work itself
  • A system that survives staff turnover
Compliance Framework Embedded

Every citation. Every section. Inline.

The inspector should never have to ask why a particular condition, time point, or specification was chosen. Every choice in a StabilityForge protocol is cited inline to its source guideline — and printed in the final document the same way.

ICH Q1A(R2)
Stability Testing
Storage conditions, study design, significant change definitions. The backbone of every protocol.
ICH Q1B
Photostability
Confirmatory design Option 2 for products susceptible to photodegradation.
ICH Q1D
Bracketing & Matrixing
Reduced study designs with formal justification for analogous formulations.
ICH Q1E
Statistical Evaluation
Regression analysis with 95% one-sided confidence limits for shelf-life estimation.
ICH Q2(R1)
Method Validation
Analytical procedures validated as stability-indicating per ICH framework.
ICH Q3B(R2)
Impurities
Degradation product specifications and reporting thresholds for drug products.
QNHP Guide v2.0
NHP-Specific Quality
Health Canada's NHP framework for identification, assay, and microbial limits.
NHPR §44–46
Expiry Data Requirements
The regulation behind the claim. Every shelf-life statement is defensible against this.
Who Buys StabilityForge

For the people on the line when the inspector arrives.

If you're accountable for showing the chain of evidence behind a shelf-life claim, you're the person we built this for.

NHP

NHP Manufacturers

Single-site or multi-site operations managing 10–500 SKUs. Direct-to-consumer brands, supplement formulators, herbal product lines.

CMO

Contract Manufacturers

CMOs running stability programs for multiple client brands. Auto-numbering and project workspaces keep client portfolios cleanly separated.

QA

QA / QC Managers

The people running stability operations day-to-day. You stop being the single point of knowledge failure. The system becomes the institutional memory.

RA

Regulatory Affairs

Submission-ready documents on demand. NHPD-aligned formatting. No more reconstructing expiry justification the week of filing.

Built On The Floor, Not In The Cloud

Compliance designed by manufacturing, not by software.

StabilityForge wasn't designed by software engineers reading regulations. It was built by manufacturing supervision leadership with three decades of production-floor experience — people who have stood beside the inspector, answered the question, and felt the consequence of an unfindable file.

Every workflow choice is grounded in how real GMP operations actually function. The auto-numbering convention exists because document numbering has always been an audit finding. The version history exists because revision control is a recurring observation. The expiry justification automation exists because nobody should rebuild that document under submission deadline pressure.

Building tools the people on the floor actually want — not the tools software vendors think they need. — Moe Elahresh · Founder, Victory Hour Multimedia Inc.
30+
YearsManufacturing supervision leadership behind the system design.
10%
Non-NegotiableEvery dollar Victory Hour generates supports the fight against world hunger.
100%
Citation CoverageEvery protocol section references its source guideline. Inline. Always.
90s
Inspector ResponseTarget time from question to documented answer. Designed for it.
Pricing

Less than one day of a stability coordinator's time. Per month.

Anchor pricing to what it replaces: one FTE stability coordinator costs $75K–$120K/year. One avoided audit finding pays for three years of StabilityForge. Decide accordingly.

Tier 01 · Standard

For single-site NHP manufacturers

Implementation$4,997 one-time
Then$297 /month Year 1 total: ~$8,561 · Year 2+: $3,564/yr
  • Up to 50 active products
  • Unlimited protocols & time-point reports
  • Version control & CSV exports
  • Print-ready documents (ICH/NHPD format)
  • Email support + monthly office hours
Book Demo
Tier 03 · Enterprise

For contract manufacturers & validation-driven environments

From$24,997 implementation
Then$1,497+ /month Custom pricing · scoped to deployment
  • White-label deployment
  • IQ/OQ/PQ validation pack
  • QMS / ERP integration
  • On-site or virtual full-team training
  • Dedicated implementation specialist
  • Custom regulatory module extensions
Talk to Sales

Consultant Partner Program — $4,997/year

For GMP, QA, and RA consulting firms. Deploy StabilityForge into unlimited client engagements, co-branded with your firm. One flat annual license. Partner directory listing included.

Become a Partner
Questions Buyers Ask

What you'll want to know before booking.

Where does our stability data go? Is it secure?
Your stability data lives in your browser's local storage by default — never leaves the device unless you choose to export it. The optional AI narrative feature is the only outbound call, anonymized, routed through Cloudflare Workers with no data retention. For enterprise deployments we provide self-hosted, air-gapped, or on-prem options. We'll send you the data flow diagram before your Audit Readiness Assessment.
We have a QMS already. Doesn't this duplicate it?
StabilityForge sits next to your QMS — not on top of it. Your QMS handles SOPs, CAPAs, deviations, change controls. StabilityForge handles the four stability-specific documents your QMS probably doesn't model natively: the protocol, time-point reports, pass/fail evaluation, and expiry justification. We integrate with Veeva, MasterControl, TrackWise, and others via document export at minimum, custom integrations at the Enterprise tier.
How long does deployment take?
Standard tier: 5–10 business days from contract signature. Professional: 10–20 days. Enterprise: scoped to validation requirements, typically 30–90 days including IQ/OQ/PQ documentation. The Audit Readiness Assessment itself takes 20 minutes and you walk away with a sample protocol regardless of whether you move forward.
Do we need to validate the system?
Pharma-grade environments do. NHP environments vary by company maturity. The Enterprise tier includes a full IQ/OQ/PQ validation pack designed around GAMP 5 Category 4 (configurable software) framing — your validation team will recognize the structure immediately. Standard and Professional tiers include validation outline documentation; full IQ/OQ/PQ is an optional add-on at any tier.
What about existing stability data? Can we migrate it in?
Yes. The Implementation fee includes migration support: existing protocols are converted to StabilityForge-numbered documents, historical time-point results can be entered as legacy reports against the migrated protocol. Most companies migrate their most-exposed SKUs first (anything heading to NHPD submission or recent inspection) and bring the rest in over the first quarter.
Can we build this ourselves?
You can. Most companies that try take 6–18 months and burn $80,000–$200,000 in engineering time before they have something equivalent, and then they maintain it forever — including regulatory updates. We've already built it, we maintain the regulatory references, and we're $4,997 to deploy. The question is whether stability software is your core competency or whether NHP manufacturing is.
Health Canada hasn't asked us for this format specifically.
Health Canada doesn't mandate format — they mandate substance. NHPR §44–46 requires stability data sufficient to support the expiry claim under labeled storage conditions. What inspectors increasingly ask for is the traceable chain: protocol → results → evaluation → conclusion. StabilityForge isn't selling a format requirement. It's selling defensibility.
What's the difference between this and big-pharma stability software?
Most stability software was built for big pharma — $50,000+ to deploy, six-month onboarding, feature sets that overshoot the NHP use case by 10x. We built StabilityForge specifically for the Canadian NHP industry: Climate Zone II baked in, NHPD references inline, NHP-specific dosage form templates, deployable in days. We're not competing with Veeva or LabWare on feature count. We're competing on time-to-value for NHP.
The Next Step

Book a 20-minute Audit Readiness Assessment.

No demo pressure. No proposal. We open one of your active NPN products, walk it through the StabilityForge frame, and you walk away with three concrete deliverables — yours to keep regardless of whether you move forward.

DELIVERABLE 01

Audit Gap Report

A documented assessment of where your current stability documentation chain has exposure under ICH and NHPD review.

DELIVERABLE 02

Sample Protocol

A fully populated ICH-aligned stability protocol generated for one of your active products. Yours to use, edit, or compare against your own.

DELIVERABLE 03

Citation Map

A regulatory citation reference for your most-exposed SKU, mapping each compliance touchpoint to its source guideline.

No credit card · No commitment · Deliverables are yours
SF
StabilityForge AI
Project-Based NHP Protocol Engine
ICH Q1A(R2) NHPD Site Saved
SF

StabilityForge

The Operating System for Your NHP Stability Program
Aligned To
ICH Q1A(R2) · Q1B · Q1D · Q1E
Health Canada NHPD
NHPR (SOR/2003-196) §44–46
When the inspector asks for your stability data, what do you hand them?
stabilityforge.ca
Victory Hour Multimedia Inc.
Windsor · Ontario

The Problem

  • Documentation lives everywhere except where you need it.Word drafts. Excel trackers. Email threads. Shared drives no one has cleaned in two years.
  • Pass/fail is decided from memory.The QA manager remembers the acceptance criterion. The lab tech remembers the result. Nobody documents the comparison.
  • Expiry justification is rebuilt under deadline pressure.Submission week. Inspector visit. Recall investigation. Always too late, always reconstructed.
  • The program lives in one person's head.Stability coordinator resigns. Replacement spends 60 days reconstructing the institutional memory.

The System

Four documents. One controlled chain. Auto-numbered, version-controlled, ICH-cited inline.

01PROJECT
02PROTOCOL
03REPORT
04CONCLUSION
▸ AUDIT-READY · INSPECTOR-RESPONSE IN 90 SECONDS

What It Replaces

Today

  • Word protocol drafts
  • Excel result trackers
  • Email-based handoffs
  • 4pm Friday pass/fail decisions
  • Expiry rebuilt at submission
  • Two weeks of audit prep

With StabilityForge

  • Auto-numbered protocols
  • Linked time-point reports
  • Single controlled workspace
  • Auto-evaluated vs. spec
  • Generated at every time point
  • Audit prep IS the work

Who Buys It

NHP
Manufacturers
CMO
Contract Mfg
QA/QC
Managers
RA
Affairs

Compliance Framework Embedded

Every protocol section cites its source guideline inline — printed in the final document the same way.

ICH Q1A(R2) ICH Q1B ICH Q1D ICH Q1E ICH Q2(R1) ICH Q3B(R2) QNHP v2.0 NHPR §44–46 USP <711> USP <791> USP <2021> USP <51>

Pricing

TierImplementationMonthly
Standard
Single-site NHP, ≤50 SKUs
$4,997 $297
Enterprise
CMO, validation pack, integration
$24,997+ $1,497+
Consultant Partner
GMP / RA firms, unlimited clients
$4,997 / year flat license

Anchor: One stability coordinator FTE costs $75K–$120K/yr. One avoided audit observation costs $15K–$50K. One avoided recall costs $100K–$500K+.

Book a 20-min Audit Readiness Assessment

You walk away with three concrete deliverables — yours to keep Documented audit gap report · Sample stability protocol for one of your products · Regulatory citation map for your most-exposed SKU. No proposal pressure.
Book Assessment