Drug Stability Services for Pharmaceutical Products
Ensure the shelf life, safety, and quality of your drug product with our expert CDMO stability testing services.
At Eirgen, we specialize in ICH-compliant drug stability studies for pharmaceutical and veterinary products. As a trusted CDMO and CMO, our integrated stability testing services support your product from development through commercialization - delivering robust data for regulatory submissions and global market approval.
What is Drug Stability Testing?
Drug Stability testing is essential for determining the shelf life and storage conditions of pharmaceutical products. Our validated processes identify how environmental factors - such as temperature, humidity, and light - impact drug quality, safety, and potency over time.
Why Does Drug
Stability Testing Matter?
Pharmaceutical stability testing is essential for:
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Establishing product shelf life
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Defining storage conditions
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Supporting regulatory submission
Our drug stability services ensure your products maintain potency, safety, and efficacy throughout their intended lifecycle.
Our Drug Stability
Testing Capabilities
ICH-Guided
Stability Programs
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Long-term, accelerated, and intermediate condition testing.
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Global climate zone simulations (ICH Zones I-Vb)​
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On-going stability testing for commercial products.
Forced Degradation & Analytical Support
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Forced degradation studies to assess active ingredient breakdown.
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Method development and validation per ICH guidelines.
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Stability-indicating assays and impurity profiling.
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Custom analytical method development for oral solids, modified release, and HPAPIs
State-Of-The-Art
Stability Facilities
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ICH-compliant stability chambers and walk-in rooms.
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24/7 monitored environments for temperature and humidity.
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Full validation to support regulatory submissions
State-Of-The-Art
Stability Chambers
Our GMP-certified facilities house;
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Walk-in stability rooms and calibrated chambers
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Real-time environmental monitoring systems with alarms
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Full chain-of-custody documentation​
Integrated CDMO Services
Formulation Development
Tailored to partners stability needs
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GMP
Manufacturing
For clinical and commercial batches
Packaging &
Distribution
Global Reach to over 60 countries worldwide
Research & Development and NPI
Stability monitoring from R&D to post-approval
Why Partner With Eirgen?
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Decades of expertise in drug development and manufacturing
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Proven track record with global regulatory submissions
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Flexible, responsive, and client-focused service
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Trusted by leading pharma and veterinary companies
Global Regulatory
Compliance
Our drug stability services align with international regulatory expectations;
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Fully compliant with ICH Q1A-Q1F, FDA, EMA, and WHO guidelines
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Comprehensive documentation support for IND,NDA, ANDA, MAA, and other global filings
