Our unique integration of chemistry, materials science, and toxicology delivers a comprehensive drug safety assessment approach to packaging, safety, stability, and compliance. 

For drug products, we provide expert chemical risk assessments, including the determination of qualification limits for impurities and degradation products in drug substances (API) and drug products, in accordance with ICH Q3 series guidelines. We also perform Potential Genotoxic Impurity (PGI) assessments under ICH M7 guidance, evaluating the mutagenic potential of impurities to ensure patient safety.

Backed by global regulatory expertise and full lifecycle support, Chemva helps bring therapies to market faster, saving time and resources without ever compromising drug quality.

Applicable Guidelines and Standards: ICH M7, ICH Q3, USP <1663>, USP <1664>, EU MDR, Applicable FDA Guidance Documents, and other vertical standards or Regional Guidance Documents