With more than 60% of the NDAs submitted in eCTD format in 2010, the eCTD can be regarded as the de-facto submission standard to the FDA.
Our team has been responsible for the creation and succesful filing of several U.S. eCTD lifecycles incl. NDAs for New Chemical Entities and INDs. Although we can deliver electronic submissions to the FDA directly via Electronic Submission Gateway upload, an U.S. - based agent is required due to legal requirements.
Due to the increasing demand of services for the U.S. market especially from smaller companies without any own presence in the Unites States, we have build a Business Alliance with our new partner Grace Pharma LLC.
