Cytotech Labs meets newly established FDA filing requirements by providing an electronic Common Technical Document (eCTD) format for clinical trial submissions, which is rapidly becoming the required standard of regulatory authorities around the world.

“FDA has mandated the eCTD format for electronic submissions to the Center for Drug Evaluation and Research (CDER) starting 1 January 2008. The European Union…accepting electronic-only marketing applications in eCTD format by 2009 and Health Canada has implemented…eCTD submissions.”

Cytotech Labs eCTD services include:

• FDA Validated Electronic Common Technical Document (eCTD) Submission software
• Preparation and Filing of FDA New Drug Application (NDA).
• 21 CFR Part 11 compliant
• Management of submissions using FDA/ICH standards, technology and methods
• Efficient and internationally agreed to formats
• Web-based document management, including access and version control, as well as electronic signatures
• Clinical trial management system (CTMS)