FAQ
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FAQ
  • Are your model services compliant with international standards?

    Yes. We have obtained AAALAC and ISO9001 certifications, and conduct studies in accordance with GLP principles, with experimental operations following FDA guidelines. Our data meets IND filing requirements of major global regulatory authorities including the US and Europe.
  • What NHP autoimmune disease models do you offer?

    We provide 50+ NHP models covering 20+ diseases in six systems (skin, joint, digestive, respiratory, neurological, endocrine), including rheumatoid arthritis, atopic dermatitis, multiple sclerosis, etc. Customized model development is also available.
  • Do you offer customized NHP autoimmune model services?

    Yes. We can customize exclusive NHP autoimmune models based on your drug targets and disease mechanisms. Relying on our NHP test bases in Guangxi and Suzhou, we can provide full-process customization from model construction to efficacy evaluation.
  • What does your IND application support service include?

    Our IND application support covers the entire process: study protocol design, experimental data collation, and application document preparation. With over 500 IND application experiences for autoimmune drugs, our team can assist in solving problems like model validation and data compliance during the application.
  • How to initiate and complete an autoimmune preclinical research project?

    The process is: ① Initial consultation (communicate drug type and research needs);
    ② Protocol design (customize model and research plan);
    ③ Contract signing;
    ④ Project execution (model construction, efficacy testing);
    ⑤ Report delivery (including data interpretation).
  • What is the professional background of your technical team?

    Our core technical team has over 20 years of experience in autoimmune drug development, with most members from international pharmaceutical companies. All project leaders hold master’s or doctoral degrees, with an average of 8+ years of experience, providing professional technical support.
HKeyBio is a China-based, globally-focused preclinical CRO dedicated exclusively to the fields of autoimmune and allergic diseases. 

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Phone: +1 2396821165
Email:  tech@hkeybio.com
Add: Boston site 「134 Coolidge Ave, Suite 2, Watertown, MA 02472」
China site「Room 205, Building B, Ascendas iHub Suzhou, Singapore Industrial Park, Jiangsu」

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