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AMADOR BIOSCIENCE

A Partner for Success

Amador is committed to providing exceptional quality solutions and a flawless customer experience as a full-service CRO for biotherapeutics development and related services. Our laboratory, clinical research, strategic consulting, and regulatory reporting services comply with international standards (GLP/GCLP) and government regulations. 

From initial analysis to the final product, our objective is to assist our customers with FDA approval of novel or improved biotherapeutics by modeling and portraying the data to highlight the key findings. In an ever-evolving industry, Amador Bioscience aims for innovation and delivery. Explore our site and see for yourself, we love what we do, and we’re sure that you will, too.

A Global & Small-Scale Provider

Amador Bioscience operates in biotech hubs of both the US and China. Our trans-Pacific capability effectively supports global development and regulatory filings for your project.

Amador has a fully staffed GLP bioanalytical lab in China, specializing in large molecule PK/ADA and assay development. We plan to open a US-based lab in fall/winter 2021. 

Amador assigns a dedicated, cross-functional team for each study to collaborate with your team from start to finish.

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Amador Bioscience

A Partner for Success

At Amador Bioscience, we hold ourselves to the highest standard and believe in full transparency within our team and with our customers. For that reason, our process includes many rigorous practices and procedures to ensure the result is the best it can be. Some of our key features are described below.

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Experienced Team

Only the Best

Amador's team of professionals, 65% of whom hold advanced degrees, brings numerous years of pharmaceutical experience from small and large companies worldwide. We work together with you and your team to ensure your project is executed with extreme care and quality. We are dedicated to your success and maintaining seamless communication and collaboration as an extension of your company.

AMADOR BIOSCIENCE
OUR SERVICES

Toxicokinetics, Clinical Pharmacokinetics & Immunogenicity Data Analysis

Modeling & Simulation

Statistical Programming

GLP and FDA 21 CFR Part 11 compliance; Fully validated computer and software systems; Implemented Quality Management System (QMS)

Translational PKPD M&S; Pharmacometrics; Exposure-Response Analysis

Fully validated SAS system; Dataset Assembly; Clinical Pharmacology, Efficacy, Safety & Immunogenicity endpoint analysis

Laboratory Services

PK/PD/ADA assay development; GLP/GCLP sample analysis

Clinical Project Management

ND & clinical development strategy; Vendor selection, negotiation & monitoring; Regulatory, site and EC Interactions

Medical Writing &
Regulatory Submissions

Study protocols & reports; investigator brochure; regulatory briefing package & common technical document (CTD)