General Information.

This experience CDO program is created to help our potential clients to understand CMC
activities necessary for IND submission. Depending on your molecule types and development
strategy, this interactive program will calculate and show you a customized timeline for
your project.

How to Begin.

Please read below instruction for how to get started.

  • On each page, please select an answer that is applicable to your molecule.
  • For some of the questions, you can choose more than one answer.
  • If you would like to change your previous answer, click previous button to go back and change your answer.
  • As a result, you will receive a customized development timeline for your molecule.
  • If you would like to go back to the main page, please click the home button.

general Molecule Information

  • IND Submission Target

  • Primary Indication

  • Do you have a cell line?

    *If your answer is No, please proceed to Q3.

  • What type of the host cell line is used for your cell bank manufacturing?

  • Can you provide reference material for method development / release testing?

  • Do you have a purification process?

  • Available method development status and deliverable document?

  • Can you provide specification (Acceptance criteria) for DS/DP?

  • Do you have a formulation process?

  • What is the route of administration?

    Biopharmaceutical Drug :

cGMP Engineering Run needs to be included?

Thank you for the submission.
The customized timeline will be ready soon.