Request Procedure & Forms

Overview

We comply with GLP regulations throughout the testing process and leverage a Scientific Committee with expertise across diverse fields to produce test data with high Speciality, Reliability, Accuracy, and Reproducibility, supporting the full-cycle development of new drugs, medical devices, and food ingredients.

Request Procedure

The process proceeds in 6 steps, from consultation and quotation request to preparation of the final report.

Consultation & Application Submission

  • On-site consultation and online consultation
  • Nonclinical Study Application A&B

Contract Preparation & Approval

  • Standard form, assignment of study number

Receipt of Test Substance (Specimen)

  • Test substance receipt record
  • Test substance code assignment
  • Test substance shipment log
  • Test substance data and certificate of analysis

Designation of Study Director & Personnel

  • Designated by the Operations Director

Preparation of Study Plan

  • Preparation and review of the study plan
  • Preparation of the master study schedule

Study Plan Approval &
IACUC Protocol Approval

Personnel Assignment & Pre-meeting

  • Chaired by the Study Director
  • Discussion of the study schedule
  • Discussion of special points in the test method

Test (Control) Substance Preparation
& Vehicle Selection

Test Group Application

  • Animal request, quarantine, acclimation records

Test Group Separation

  • Recording and storage of related data

Test (Control) Substance
Preparation·Dosing·Observation

  • Test (control) substance preparation record
  • Inspection of feed, water, and environmental analysis data
  • Preparation and storage of raw study data
  • Documentation of deviations from the study plan

Study Termination

  • Necropsy-related records
  • Analysis (urine, blood, etc.) and pathology (preparation/reading)
  • Final inspection of raw study data
  • Data entry into PC and error checking

Raw Data Analysis
(1st Reliability Assurance)

  • Chaired by the study personnel
  • Handover to the statistics personnel

Statistical Analysis

  • Chaired by the principal test scientist
  • Inspection of raw study data and statistical analysis data

Study Termination

  • 1st: Study personnel
  • 2nd: Inspection by the principal test scientist
  • Handover to the Study Director

Preparation of Draft Final Report

  • Study Director
  • QAU inspection
  • Sponsor inspection
  • Attachment of QAU statement

Final Report Issuance & Amendment

  • The Study Director verifies the content and prepares the final version

Storage of Data & Specimens

  • Chaired by the data and specimen manager
  • Transfer of raw study data, etc.
  • Verification of data and specimens
  • Records of data and specimen storage retained for 5 years

Quick Links

You can check test consultation and progress status in the menus below.

Test Consultation (Online) Test Progress Status

Inquiries

For further details, please contact us by phone.

  • - Contact E-mail: glp@snuh.org
  • - GLP, pharmaceuticals, medical devices, etc.: 2072-1932