stability & shelf-life

things change,
we understand

start your study
ensure product safety & quality

Satisfy the most important regulators and encourage repeat buys with consistent quality and confident safety.

meet regulatory compliance

Meet FDA, ICH Q1A, or other regulatory requirements natural products and global export products with proper documentation.

satisfy retailer & certification requirements

Satisfy retailer demands and certification standards with clear and accurate stability and shelf-life data,

built for regulatory readiness

Our studies are designed to align with FDA, ICH Q1A, and global regulatory standards from the start, so the data you generate is defensible, documented, and ready to submit.

GMP
Demonstrate compliance with CFR 21 pt 111 / 117 Good Manufacturing Practices
NDIN
Support New Dietary Ingredient Notification submissions

the study process

1 | study design

Design your study around your product’s specific needs, choosing from long-term (25°C / 60% RH) or accelerated (40°C / 75% RH) conditions, study durations from 3 to 24 months, and a full range of testing specifications including nutritional, potency, microbial, contaminants, physical, and organoleptic. Pull frequency is fully configurable: every time point, beginning only, every other, beginning/middle/end, or a fully custom schedule.

2 | proposal delivery

Submit your study parameters through a streamlined design form covering contact details, product specifications, formulation, packaging, and shelf-life goals. All submissions are reviewed by our scientific team against FDA, ICH Q1A, and cGMP standards, and you can upload supporting documents like formulas or previous COAs to help us tailor the study to your exact needs. You’ll receive a clear, detailed proposal outlining scope, timelines, and costs before anything moves forward.

3 | material submission

Once you approve the proposal, we guide you through submitting samples to the lab. Each item is received, inspected, labeled, and placed into validated stability chambers with full environmental controls. From day one, samples are tracked and logged in our LIMS with complete traceability. Your team is kept informed on receipt confirmation, pull dates, and testing schedule so you always know what’s happening next.

4 | study launch & execution

Your stability study is conducted under the exact conditions specified, whether long-term, accelerated, or custom. At each time point, our scientists perform the designated microbial, chemical, physical, or sensory tests and upload results directly to your secure client portal. All testing is performed using validated methods aligned with industry and regulatory expectations, and you’ll receive a Certificate of Analysis at each interval.

5 | reporting & completion

At the conclusion of your study, we deliver a final report with compiled results, graphical trend data, and a clear shelf-life recommendation. The report is ready to support label claims, regulatory filings, and retail compliance. Our team is available to walk through the data and help you apply the findings, whether you’re updating labels, reformulating, or preparing for a product launch.

let’s begin

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