What does set us apart? Our integrated expertise across chemistry, materials science, toxicology, and biocompatibility, delivering a uniquely comprehensive approach to safety and compliance. 

For combination products, Chemva’s solutions for combination products span the full development cycle, from materials selection, processing support, and performance prediction to preparing Biocompatibility Evaluation Plans (BEP), Materials Risk Assessments (MRA), Toxicological Risk Assessments (TRA), and Biological Evaluation Reports (BER). We also conduct failure analysis and recommend preventive measures to support product reliability and safety. 

In addition to materials and biocompatibility support, we provide expert chemical risk assessments, including the determination of qualification limits for impurities and degradation products in drug substances (API) and drug products, following ICH Q3 guidelines. Our services further include Potential Genotoxic Impurity (PGI) assessments under ICH M7 guidance, evaluating the mutagenic potential of impurities to ensure patient safety and regulatory compliance. 

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

Applicable Guidelines and Standards: ISO 10993 Series, ISO 18562, USP <87>, USP <88>, USP <661>, USP <381>, USP <1663>, USP <1664>, EU MDR, Applicable FDA Guidance Documents, and other vertical standards or Regional Guidance Documents