• 高效提供 eCTD 的所有需求 (eCTD 编辑与递交, publishing and submission)
• 最近几年中，我们已编辑与递交 FDA a large number of applications/amendments
• 联系我们 (见下面链接)
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.