Common Technical Document


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Common Technical Document

A format adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for organising applications of pharmaceuticals for human use to the regulatory authorities.
References in periodicals archive ?
Suggested links: ISI, Association of Southeast Asian Nations, electronic Common Technical Document (eCTD), ISIRegTracker, ISIPublisher
0 is compliant with the life science industry's taxonomy standards, including: International Conference on Harmonization (ICH), Electronic Common Technical Document (eCTD), E3 Essential Clinical Documents and the DIA EDM Reference Model.
ISI was among the first professional services firms to deliver electronic submissions to the industry and has since delivered thousands of electronic and electronic Common Technical Document submissions.
SharePoint Server provides users the ability to control information rights, digitally sign key review documents in a SAFE-compliant manner, manage electronic Common Technical Document (eCTD) metadata or clinical trials documents, and publish to PDF and Microsoft XPS, the two leading electronic formats for regulatory submissions.
Comprehensive Compliance Solution Meets Industry's Electronic Common Technical Document (eCTD) Requirements, Streamlines Processes and Reduces Delays
The Tianjin, China, office focuses mainly on document processing, and is expected to help ISI double its processing of electronic Common Technical Document (eCTD), the preferred format for electronic regulatory submissions, over the next year.
Biometrics and CDISC Conversion Services Provide Single-Vendor Support for Electronic Common Technical Document Submissions
The challenge for today's regulatory operations team is significant: With the electronic Common Technical Document (eCTD) as the standard format for submissions, products are being submitted in multiple regions and in multiple formats, creating administrative and reporting hurdles.
The company enabled the first-ever electronic new drug application to the FDA and is at the forefront of the industry's move to adopting the electronic Common Technical Document (eCTD), the new drug application standard that will be required by the FDA at the end of 2007.
Based on Boehringer Ingelheim's decision to procure the software using the SaaS model, the company was able to comply with the electronic Common Technical Document (eCTD) format developed by the International Conference on Harmonisation.