The Common Technical Document (CTD) is a set of specifications for a dossier to register medicines. After the United States, European Union and Japan, the CTD has been adopted by several other countries including Canada, Australia and Switzerland. The Paper CTD is destined to be replaced by its electronic counterpart, the eCTD.
It's difficult for different foreign regulatory authorities to effectively review the various formats of technical documents submitted by life sciences companies for consistent approval standards. Suppose you are looking to register your medicines with international regulatory authorities. One essential requirement is to professionally translate your new drug’s technical information on quality, safety, and efficacy to ensure compliance with the harmonized electronic submission and good regulatory review practices that are widely required internationally.
MedTrans provides industry-leading, centralized document translation solution that is perfectly engineered to meet the requirements of the Common Technical Document (CTD) translation standards.
The Common Technical Document is developed by the International Conference on Harmonisation (ICH) and divided into five modules and all of which must be adequately translated into the required languages to be eligible for harmonized electronic submission in the corresponding countries. The five modules are:
- Module 1: Administrative information and prescribing information
- Module 2: Common technical document summaries (Overview and summary of the drug’s quality, safety, and efficacy on humans.)
- Module 3: Quality (pharmaceutical documents which describe the format and organization of the chemical, pharmaceutical, and biological data relevant to the application.)
- Module 4: Safety (nonclinical study reports, preclinical documents which provide objective and critical assessment of the pharmacology and toxicology evaluation of the pharmaceutical.)
- Module 5: Efficacy (typical clinical trial documents which include clinical studies, protocols, and patient reports.)
Dossier Documents Matrix
Detailed guidelines are provided describing the content of each module and the majority of submissions must now follow the CTD format for submission dossiers. We have expert experience translating all five of the CTD document modules. Our team offers 24/7 support with quick turnaround times to ensure you get the service you need. MedTrans helps pharmaceutical companies, contract research organizations, and biotechnology firms stay ahead of the competition with one professionally translated technical document at a time.
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