11
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 m ...Product Expert
Download product information