A Partner for Success,

A Leading Partner for Biotherapeutics Development.

Services We offer

Amador Bioscience is committed to providing many of the various services required to achieve approval of a novel therapeutic. Our consulting strategy uses the latest technologies, industry best practices and applies strict quality control procedures. We are known for facilitating innovative development.

Since our inception in 2018, Amador Bioscience has actively supported over 100 clinical projects, including multiple IND and CTD filings in the US and China. Current clients range from cutting-edge biotech start-ups to multinational pharmaceutical companies. We perform a wide range of services in the categories below.

Contact Us
 
Pipetting Samples
Clinical Pharmacology, DMPK & Pharmacometrics
  • Reporting services (NCA & PK/ADA/CSR)

  • Translational PK/PD

  • Population Modeling

  • Clinical Trial Simulations

  • Biostatistics & SAS Programming

  • Exposure-Response Assessment

Laboratory Services

  • Design of discovery, preclinical & early-stage clinical studies.

  • Indication selection & patient stratification plan

  • Biomarker discovery, characterization, & implementation

DNA
Doctor's Clinic
Precision Medicine
  • Design, monitoring & interpretation of nonclinical safety studies

  • Monitoring & reporting of clinical safety results

  • Addressing inquires from agencies, partners or investors

Biostatistics & Programming

  • Clinical study design, SAP

  • Statistical assessment of clinical efficacy & safety

  • Bioequivalence assessment

  • SAS programming; TFLs, SDTM and ADaM datasets

  • Data meets cDISC standards

Investment Chart
Image by Science in HD

Clinical Development

  • Domestic & global clinical  development plan, preparation, execution & project management.

  • Clinical study protocol design, ICF/CRF

  • Rigorous QA, QC & global HA inspection prep/training

  • Deep knowledge of IHC-GCP & local requirement

  • Relationship with Chinese medical centers and local vendors.

Medical Writing & Regulatory Submissions

  • CSR, IND, & CTD preparation, publishing & submission

  • Regulatory meeting requests, planning, briefing packages & representation

  • Publication strategy & due diligence

  • Our team in conjunction with our document templates, SOPs, and document lifecycle management process deliver top-notch documents.  

Writing%20on%20Tablet_edited.jpg

Have questions about our services and how we can help you? Reach out today. We are happy to help.