Services
- Drug Metabolism
- Drug Transporters
- Enzyme Induction
- Enzyme Inhibition
- Hepatotoxicity
- In Vivo ADME
- Regulatory Compliance
- Technology Support
- XenoTech Promotions
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Calendar of Events
| Date | Event Name |
|---|---|
| May 23, 2012 | Webinar: PBPK modeling |
Knowledge Management
XenoTech’s Knowledge Management group focuses their efforts on providing efficient, high quality document and reference material services in support of contract studies and products production.
The Knowledge Management Group contributes expertise and support to:
- Preparation of contract study reports meeting our sponsors’ documentation requirements and ICH eCTD specifications
- Archiving and maintenance of facility and contract study records meeting applicable regulatory requirements
- Control and management of SOPs and data recording forms
- Management and acquisition of scientific reference materials
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.
