Post-IND Maintenance

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.

Background

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.

Timeline overview of post-IND submissions.

Fig.1 Timeline of pre-IND meeting.

Post-IND Services

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
  • New protocol/Change in the protocol (IRB approval is required after submission)
  • New investigator (within 30 days of being added)
Information Amendments 21 CFR 312.33
  • CMC
  • Pharm/Tox
  • Notice of discontinuance
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.)
Please contact us for details.

IND Safety Reports 21 CFR 312.32
  • 15-day report (calendar)
  • 7-day report (calendar)
  • MedWatch Form (Form FDA 3500A)

Please contact us for details.

Withdraw an IND 21 CFR 312.38

Sponsor may withdraw IND at any time w/o prejudice

  • Notify FDA of the reasons
  • End clinical investigations
  • All drug stock disposed of or returned to the drug manufacturer

Highlights

  • ✔ Qualified publishing and submission experts
  • ✔ End-to-end roadmap from registration strategy to compiling submissions to lifecycle management
  • ✔ Document level publishing available
  • ✔ Quick turnaround time.

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 lab research only, cannot be used for any clinical use.

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