Compare CDMOs with ICH stability testing capabilities. Filter by chamber capacity, ICH condition support, and regulatory filing experience.
454 companies listed
Stability testing determines how a drug product changes over time under defined storage conditions (temperature, humidity, light). ICH guidelines (Q1A-Q1E) specify the conditions, timepoints, and statistical analysis methods used globally. Stability data is required for regulatory submissions to establish shelf life and storage conditions.
CDMOs offering stability services need: validated stability chambers (temperature and humidity controlled), GMP-compliant analytical testing capabilities, sample management systems for multi-year programs, and regulatory expertise to design study protocols that support global filing strategies.
Poland
Selvita is a Poland-based integrated drug discovery and development service provider (CRO) with expanding CDMO capabilities following its 2024 acquisition of PozLab. The company offers comprehensive services spanning drug discovery (medicinal chemistry, pharmacology, DMPK, protein sciences), drug development (analytical, formulation, clinical trial batch manufacturing), and contract testing under GMP/GLP. Selvita has operations in Krakow, Poznan, and Wroclaw (Poland) and Zagreb (Croatia).
United States
Triclinic Labs is a US-based contract research organization specializing in solid-state chemical development and materials characterization. Founded in 2009, they are an FDA-registered and inspected laboratory (2024) with a DEA Controlled Substance License (Class I-V). They provide physical and analytical chemistry services including solid-form screening, polymorph analysis, and intellectual property support. They do NOT manufacture drugs.
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