Gap Analysis & Regulatory Consulting
Partner with a trusted team to meet your development program at its current stage and develop an efficient path towards your product development goals.
TD2 can help identify and mitigate the risks to your therapeutic program. Many emerging Biotech and small Pharma pour money into a development program with the hope that their product will reach the market. Our proven approach of conducting a Gap Analysis will enable you to optimize your resources, identify and design a more efficient roadmap, and ultimately get your Oncology drug into the clinic faster. We customize a team specific for your therapeutic – cell based, mAbs, or small molecule.
Key questions a Gap Analysis addresses before you submit your IND to the FDA
- What are the FDA requirements to get your product into the clinic?
- Does existing data satisfy those requirements?
- What is the most efficient way to satisfy any remaining requirements?
- Assessment of work to date
- Identify missing elements in your data package
- Develop a plan for additional data/studies
- Summary to inform strategic direction, efficiency, and de-risking development
Advantages to your Program
- Provides a strategy and roadmap for getting to a successful FDA filing
- A validated drug development plan that can be used to inform investors and shareholders
TD2’s Regulatory Affairs and Translational Research 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.