Frequently Asked Questions
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Regulatory
What is eCTD?
Electronic Common Technical Document (eCTD) is a technical specification developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for the purpose of providing criteria for industry when transferring product registration information in electronic format to the applicable regulatory agency. XenoTech follows eCTD specifications when preparing contract service reports.
To learn more about ICH, visit their website at www.ich.org.
The latest version of the eCTD specification (PDF).
What is the difference between GLP and non-GLP studies?
XenoTech conducts both GLP-compliant and non-GLP studies to high standards of quality following applicable SOPs; however, non-GLP studies may not comply with all regulatory requirements. In a non-GLP study:
- Quality Assurance audits are not conducted.
- Audit trails may not be present on data.
- Analytical methods may not be validated per FDA guidance.
- Data summaries can be prepared in place of final reports.
For more information, refer to XenoTech's poster, A comparison of regulatory requirements applied to an FDA GLP-compliant and non-GLP study at XenoTech (PDF).