TD2 provides a broad range of regulatory expertise and services with integrated project management to ensure that your program runs seamlessly into clinical development. Our reputation of excellence in strategy, writing and submissions stems from our industry experienced team who are committed to the success of our clients. Whether your organization needs a full turnkey project or a customized selection of services, TD2 stands ready to meet all your regulatory affairs needs.

Pre-Investigational New Drug (IND) Activities
TD2 has extensive experience with the FDA's pre-IND consultation program and can assist with an evaluation for a Sponsor's needs for FDA pre-IND consult. Furthermore, TD2 excels in preparation for the pre-IND meeting request, information package, and attendance at the meeting.

Investigational New Drug (IND) Activities
TD2 offers a wide array of services to move compounds through the IND process and into the clinic. Services include:

• Initial IND application, management, writing, compilation (paper and / or electronic), and 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), Nonclinical (pharmacokinetic, pharmacology, and toxicology sections), Clinical and other application requirements.
• Investigator's Brochure and Phase IIB clinical protocol writing.
• Compilation, assembly and publishing of the IND (including formatting, organizing, labeling, duplicating, and volume assembly) for paper submissions. eCTD (ICH compliant) submission capable as well.
• Communicate with regulatory agencies on behalf of the sponsor.

FDA Communications
TD2 will act as the IND agent to the FDA and other US regulatory agencies as necessary for non-US sponsors.

Continued Support
Once the IND is in place, TD2 will work to keep all IND information current and in compliance with FDA regulations (IND maintenance). TD2 can assist with maintaining the regulatory requirements during the clinical trial, including IND amendments, IND annual reports, and expedited safety reporting for serious adverse events (SAE).

Compliance
An essential component of the company's program will be the use of standardized procedures. Standard operating procedures (SOPs) will be written on a per client basis to ensure consistent operations, study results and compliance with EPA, Office of Laboratory Animal Welfare at the USDA, FDA and other state and federal environmental regulations as required.