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Key Facts
- Comprehensive Stability Programs – We offer real-time, accelerated, intermediate, stress, and in-use stability testing under ICH- and GMP-controlled conditions, ensuring complete support from development through commercialization.
- Regulatory-Ready Workflows – Every study is designed with FDA, EMA, and ICH requirements in mind, featuring validated stability chambers, electronic data capture, full audit trails, and inspection-ready documentation.
- Broad Modality Expertise – With decades of analytical experience, we support biologics, biosimilars, small molecules, and advanced drug products—delivering tailored stability strategies that accelerate submissions and ensure long-term product quality.
Categories
Research institutes, laboratories Research, development
Product information
Nuvalore delivers ICH- and GMP-compliant stability testing to ensure drug products remain safe, effective, and compliant throughout their lifecycle. Our programs support confident shelf-life assignment, storage recommendations, and global regulatory submissions.
We offer a full spectrum of studies including real-time, accelerated, intermediate, stress, and in-use testing, all performed in validated, continuously monitored stability chambers under FDA, EMA, and ICH requirements. From protocol design through submission-ready reporting, our workflows are built for scientific rigor and inspection readiness.
With deep expertise across biologics, biosimilars, small molecules, injectables, orals, and topicals, nuvalore provides tailored stability solutions that reduce risk, ...Product Expert
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