TD2's Regulatory Team excels in evaluating our clients' needs, understanding how to craft questions to the FDA, preparing the Pre-IND Meeting Request, Pre-IND Information Package, and attendance at the Pre-IND Meeting or Teleconference.
Investigational New Drug (IND) Application Activities:
TD2 can fully support all activities related to the IND Application and IND submission. Services include:
- IND writing, IND compilation and IND submission (both paper submission and electronic submission).
- 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 sections).
- Medical Writing Services including Investigator's Brochure (IB) Development, clinical protocol writing and design (including clinical strategies).
- Compilation, assembly and publishing of the IND (including formatting, organizing, labeling, duplicating, and volume assembly) for paper submissions. eCTD (according to ICH guidelines) submission capable as well.
- Communicate with regulatory agencies on behalf of our client.
TD2 can also be responsible for supporting IND maintenance once the IND has cleared FDA review. TD2 can act as the primary contact with the FDA, and maintenance activities include the following:
- IND Protocol Amendments
- IND Information Amendments
- IND Safety Reports
- IND General Correspondence for Fast-Track Designation Request
- IND Annual Report
- Informal meetings with FDA including: Sponsor preparatory teleconferences, FDA meeting(s) via teleconference, Post-FDA meeting debriefing meeting, and preparation of Sponsor meeting notes
- Project management