Analysis Technology Support

Analytical method development / Analytical method validation / Elucidation & Characterization

Analytical method
Analytical method
Batch release test
Elucidation &
Characterization for CTD

For customers who have difficulties in setting up new tests related to ICH M7 and ICH Q3D, we use our cGMP system to perform tests on those compound that are difficult to manage daily tests on for genotoxic impurities and elemental impurities using special equipment, and we also perform test method development and verification, if necessary.

We satisfy the requirements for the cGMP system to test the physical and chemical properties, as well as the structural confirmation to be written on the drug registration & data for approval (UV, IR, Mass, NMR, EA, XRD, and DSC).

Equipment Holdings for Service

Service Procedure

Step 1. Service Procedure
  • Issuance of Quote
  • Proceed with a Contract
Step 2. Proceed with the Test
  • Testing Method Development
  • Validation
  • Equipment Analysis Test
Step 3. Test Termination
  • Check Test Result
  • Fill Out Real-time Lab Note
  • Provide Certification or Test Report