Amador Bioscience

Amador Bioscience provides a wide range of services including bioanalysis, biomarker services, clinical pharmacology, regulatory affairs, and clinical research. The company offers end-to-end drug development services, covering all stages from preclinical research to Clinical Phase IV studies. With a global network of therapeutic-specific key opinion leaders, subject-matter experts, vendors, and pre-qualified investigator trial sites in the United States, Europe, and China, Amador Bioscience ensures comprehensive support for drug development projects. The company operates three GLP compliant laboratories located in California, Maryland, Michigan, Belgium, Hangzhou, Shanghai, and Beijing. Amador Bioscience provides extensive regulatory support, including regulatory strategy, authoring and medical writing, and submission and approval processes. Their bioanalysis services encompass immunoassays, LCMS, cell-based assays, flow cytometry, ELISpot assays, and molecular biology. Clinical pharmacology services include noncompartmental PK/TK analysis and reporting, statistical programming, translational modeling and simulations, pharmacometrics, and quantitative systems pharmacology. Each program is managed by a dedicated translational project manager. The company supports drug development for various therapeutic indications such as oncology, dermatology, CNS, and GI, and offers comprehensive immunogenicity assessment to aid drug approval. Amador Bioscience has established GLP facilities and local teams in the US, China, and EU, and has completed over 1600 studies from preclinical to BLA/NDA in its first five years. The company provides full-service clinical trial support under one roof and offers model informed drug development (MIDD) to guide rational clinical decision making. Their global clinical pharmacology teams support drug development and marketing approvals in the US, China, and EU.