With extensive experience of regulatory services, Creative Biolabs provides pre-IND meeting, IND publishing and submission to help gain IND approval to facilitate clinical trials of your drug candidate. In addition, we also offer post-IND services to help maintain your IND in compliance with specific regulations of agencies.
To maintain an IND, three timeline-sensitive reports are essential (see Fig.1). For IND amendments and safety reports, they need to be submitted in the event of updates or unpredictability. For annual report, it should be submitted every year, even if no studies are under progress under the IND. All submissions need to be sent to the address provided in the IND acknowledgement letter in response to the first submission.
Fig.1 Timeline of pre-IND meeting.
After IND approval, we offer a full spectrum of services to help our sponsors to maintain the IND including IND amendments, annual reports, safety reports, etc. For IND amendments, we offer publishing and submission services of protocol amendments and information amendments.
| Post-IND services | Regulatory guidelines | Dossier package and comments |
| Protocol Amendments | 21 CFR 312.30 |
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| Information Amendments | 21 CFR 312.33 |
|
| IND Annual Reports | 21 CFR 312.33 |
(Even if it did not enroll any patients; Can include various changes that were not
captured in the Information and Protocol Amendments; They expire 60 days prior the IND
effective date.) |
| IND Safety Reports | 21 CFR 312.32 |
Please contact us for details. |
| Withdraw an IND | 21 CFR 312.38 |
Sponsor may withdraw IND at any time w/o prejudice
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Creative Biolabs is committed to working with you to facilitate your IND registration for FDA. If your IND program is for other agencies, such as CFDA, EMA, Health Canada, Thailand, Australian etc., please feel free to contact us for detailed communications. eCTD, NeeS, and paper submission are all available in Creative Biolabs.
For Research Use Only | Not For Clinical Use
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