Bioanalytical Services

Pharmaron provides comprehensive analytical and bioanalytical services to support preclinical development needs, including quantitative evaluation of PK, TK, tissue biodistribution, immunogenicity, viral shedding, biomarker and dose level, etc. Test article modalities include small molecules, large molecules and products of cell and gene therapy. The analytical and bioanalytical service platforms have been developed and tailored to the needs of specific modalities to be analyzed. Our teams have been trained and grouped based on GLP- and non-GLP-compliant studies to ensure high efficiency and regulatory compliance. For regulatory filing studies, supporting IND, later phase clinical studies, NDA and BLA submissions, Pharmaron’s teams develop and validate analytical and bioanalytical methods, and analyze or assay samples as per GLP guidelines by ICH, NMPA, FDA and OECD regulatory authorities, Pharmaron SOPs and study protocols.  Our GLP facilities housing the analytics and bioanalytics platforms have been inspected successfully by FDA, NMPA and OECD GLP agencies. GLP compliant analytical and bioanalytical data generated by Pharmaron’s teams have supported a substantial number of regulatory submissions for our clients with success, over the past decade.