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.
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.
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.
Auto-coded workspace per product or product line. Every document inherits the project number.
ICH-compliant study design. Auto-numbered, version-controlled. References inline.
Time-point results per batch. Pass/fail auto-evaluated against the protocol's spec.
Expiry justification generated from results. Citations attached. Sign-off ready.
Inspector asks the question. You answer in 90 seconds. Every time.
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.
If you're accountable for showing the chain of evidence behind a shelf-life claim, you're the person we built this for.
Single-site or multi-site operations managing 10–500 SKUs. Direct-to-consumer brands, supplement formulators, herbal product lines.
CMOs running stability programs for multiple client brands. Auto-numbering and project workspaces keep client portfolios cleanly separated.
The people running stability operations day-to-day. You stop being the single point of knowledge failure. The system becomes the institutional memory.
Submission-ready documents on demand. NHPD-aligned formatting. No more reconstructing expiry justification the week of filing.
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.
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.
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.
A documented assessment of where your current stability documentation chain has exposure under ICH and NHPD review.
A fully populated ICH-aligned stability protocol generated for one of your active products. Yours to use, edit, or compare against your own.
A regulatory citation reference for your most-exposed SKU, mapping each compliance touchpoint to its source guideline.
Four documents. One controlled chain. Auto-numbered, version-controlled, ICH-cited inline.
Every protocol section cites its source guideline inline — printed in the final document the same way.
| Tier | Implementation | Monthly |
|---|---|---|
| Standard Single-site NHP, ≤50 SKUs |
$4,997 | $297 |
| Professional Multi-site, custom branding |
$9,997 | $497 |
| 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+.