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FDA GLP Study

From non-clinical studies to FDA approval, with IND and NDA consultation in one package.

Partnership

Dt&CRO × Radyus Research

Dt&CRO and Radyus Research signed a Memorandum of Understanding (MOU) on March 15, 2024, to provide services covering all stages from non-clinical trials to FDA approval, including consultation for Investigational New Drug (IND) approval and New Drug Application (NDA).

How it works

Who does what

Sponsor

    • Select service
    • Provide information
    • Consultation and consent
    • Clarify project introduction
    • Demonstrate non-clinical study strategy (administration route, indication, etc.)
    • Determine non-clinical trial item(s)
    • Confirm strategy for IND approval
    • Confirm non-clinical study design from pre-IND meeting
    • Write protocol synopsis
    • Confirm

Dt&CRO

    • Request consultation
    • Share drug / substance information / T / C
    • Consult primary study design
    • Discuss plans for consultation
    • Consult and prepare for FDA GLP study
    • Execute FDA GLP study according to drug / substance
    • Execute toxicity / efficacy / ADME study
    • Assist preparation for IND, NDA submission
    • Support interpretation / translation

Radyus Research

    • Review initial stage of consultation
    • Conduct gap analysis
    • Develop consultation plan
    • Identify category / track designation
    • Consult efficacy test design
    • Facilitate pre-IND meeting
    • Determine non-clinical trial item(s)
    • Confirm strategy for IND approval
    • Confirm non-clinical study design from pre-IND meeting
    • Review and consult essential documents
    • Write IB and clinical protocol
    • Represent sponsor in RA for IND, NDA submission
About Dt&CRO

A complete CRO service in Korea

Dt&CRO received its GLP certification in 2020. It is the only full-service provider of commissioned research in the country. The company offers a complete range of services, including non-clinical GLP toxicity, PK and efficacy testing necessary for pre-approval of pharmaceuticals, chemical substances, health functional foods, cosmetics and medical devices.

Additionally, Dt&CRO provides analysis, preclinical, clinical trial and pre-approval consulting services, making it the top and only domestic provider of a complete CRO service in the Republic of Korea.

  1. 01Safety, efficacy tests
  2. 02Evaluation of efficacy
  3. 03Analyses
  4. 04Bioequivalence
  5. 05Clinical trials
  6. 06Licensing