Pre-IND Activities

Access a suite of expert-guided regulatory resources and services from the TD2 regulatory team—including carefully crafting FDA questions, pre-IND meeting request preparation, pre-IND briefing packages, and participating with you in FDA interactions.

Investigational New Drug (IND) Application Activities

Make the IND process easier by accessing our turn-key services for authoring, building, and managing all the sections of your IND submission:

  • IND writing, compilation and electronic submission
  • We can act as the primary contact to the FDA on behalf of a US sponsor, or as the US IND agent on behalf of a non-US sponsor.
  • Technical writing of the summary sections, including the Chemistry, Manufacturing and Controls (CMC) and Nonclinical (pharmacokinetic, pharmacology, and toxicology) 
  • Medical writing services, including investigator's brochure (IB) development, clinical protocol writing and design (including clinical strategies), and Informed Consent Form (ICF)
  • IND assembly, publishing (word processing, intra- and inter-document hyperlinking, etc.) and eCTD submissions, according to ICH guidelines
  • We can communicate with regulatory agencies on your behalf.

IND Maintenance

Once your IND has cleared FDA review, you can also access ongoing maintenance as a TD2 client. By your request, we can act as the primary contact with the FDA for the following activities:

  • IND protocol amendments
  • IND information amendments
  • IND safety reports
  • IND general correspondence for Fast-Track Designation Request
  • IND annual report
  • Informal meetings with the FDA, including: sponsor preparatory teleconferences, FDA meetings via teleconference and the post-FDA meeting debriefing
  • Project management

Ask us how you can get your regulatory assessment started today.

Need help with your model selection? Contact TD2 to get more information about our murine models available for immediate use.

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