We can effectively manage all your eCTD needs (publishing and submission).
We have published and submitted to FDA a large number of applications/amendments in last a few years.
Contact us (link below).

eCTD publishing/submission (US FDA) - yearly based

Number of IND/NDA/BLA .. One IND, NDA, or BLA .. > 1 and ≤ 5 IND, NDA, or BLA .. > 5 IND, NDA, or BLA ..
Price (USD) 1, 2, 3, 4 $10,000 Contact us for package price Contact us for package price
1 Adequacy of nature and number of the documents will be verified (included). However, the content review/document editing will need additional consulting fee.
2 Quick turnaround time for eCTD publishing/submission (1-3 days in general).
3 IND, NDA, BLA, DMF, ANDA or EUA (i.e., per IND/NDA/BLA/DMF/ANDA/EUA number).
4 US FDA agent services available.

eCTD publishing/submission (US FDA) - per submission

Number of documents ≤ 5 documents > 5 and ≤ 20 documents > 20 and ≤ 40 documents
(non-major submissions)
Price (USD) 1, 2, 3, 4 $500 $1,000 $1,500
1 Adequacy of nature and number of the documents will be verified (included). However, the content review/document editing will need additional consulting fee.
2 Quick turnaround time for eCTD publishing/submission (1-3 days in general).
3 For major eCTD submssions, such as full IND, NDA, BLA, DMF, ANDA or EUA, please contact us for pricing.
4 US FDA agent services available.

Your request for eCTD publishing/submission (with company email):

 
 
 


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