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.
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