The electronic Common Technical Document (eCTD) has become the standard for numerous regulatory agencies across the world.
FDA has mandated the eCTD format for electronic submissions to the Center for Drug Evaluation and Research (CDER).
The European Union has declared that its 27 Member States must be capable of accepting electronic-only marketing applications in the eCTD format, starting in 2009, and Health Canada has implemented an electronic review environment for eCTD submissions.
Since 2006 our well experienced team at Team Tranquil prepared and helped submitting hundreds of successful electronic submissions to FDA in eCTD format for various types of applications such as NDA, ANDA and DMFs. Some of these submissions already received approval from the agency.
Team Tranquil is maintaining 100% success with electronic submissions. So far none of the submissions prepared by us received RTF from the agency.
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