Electronic Common Technical Document (eCTD) Publishing Services
The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER).
Electronic submission requirements will apply to the following types of submissions to CDER:
NDAs
ANDAs
Commercial IND applications (for products that are intended to be distributed commercially)
All subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect
Master files, such as DMFs, which are considered to be submissions to an IND, an NDA, or an ANDA
Electronic submission standards will be optional but encouraged for the following categories:
Noncommercial INDs, such as investigator-sponsored INDs and expanded-access INDs
Submissions for promotional materials for human prescription drug
Catain has in-depth knowledge and resources to handle any eCTD regulatory submissions.
Catain offers eCTD submission publishing services for NDAs, ANDAs, IND, and DMF, all at completive prices.
Why choose Catain for eCTD Publishing Services?
Complete solution for all your regulatory submission requirements, including regulatory filings in electronic format.
Client confidentiality.
Cost-effective fees and a quick turnaround time.
No upfront cost and complete support until the FDA accepts your application.
We offer an integrated service for the submission of your eCTD application, through our Electronic Submissions Gateway (ESG)
Discounted fee for multiple product filings
Quick turnaround time and online support for international clients.
Assistance for obtaining pre-assigned application number
If you have questions, please get in touch.