Full Program Management & Regulatory Consulting
Partner with a trusted, integrated team to guide your IND-enabling studies.
TD2’s expert program managers develop and manage program timelines, identify risks and critical path deliverables, and manage activities to deliver on key milestones, allowing your internal teams to focus on research and business needs. By driving the entire IND enabling process and bringing the right experts for your new drug, we work tirelessly to get your treatment to the clinic efficiently.
- Support and manage programs from determination of your lead compound all the way through IND filing and early-stage clinical development
- Milestone and deliverable tracking
- Integrated team for CMC, pharmacology, and toxicology studies
- Technical and business level interactions and support
Advantages to your Program
- Integrated technical and clinical regulatory strategy consulting to define an efficient pathway that de-risks the development of your therapeutic
- Customized team specific for your therapeutic – cell based, mAbs, small molecule
- Scenario planning and risk mitigation for development challenges
- Seamless integration of regulatory project management activities into the program plan, including Pre-IND, eCTD Module development, and Investigational New Drug (IND) application filing
TD2’s Regulatory Affairs Team engages Oncology drug development experts and strategists with proven track records of success. We leverage experienced, oncology-focused medical writers, regulatory experts in CMC, pharmacology, and toxicology, as well as regulatory program managers to provide a customized approach across all areas of drug development.