PathfiNDAr™
Building a Path to Your IND and NDA
PathfINDAr™is our proprietary expert drug development planning tool that uniquely enables our multi-disciplinary scientific staff to create your development plan. This tool is an intricate database of the drug development processes comprised of over 900 lines of detailed tasks and associated costs. When utilizing PathfINDAr™’s extraordinary data engine, PharmaDirections can work with clients to give an accurate view of their drug development program by assessing every task that needs attention. The result is a pathway to success with a comprehensive list of actions that mitigates risk, anticipates pitfalls and highlights the gaps between a client’s current program and the requirements to meet their goal. The output of PathfINDAr includes:
- Detailed comprehensive drug development list complete with risks and assumptions
- General Consulting & Strategic Planning
- Discovery
- Pharm/Tox (includes Tox, ADME, PK, & Animal Studies)
- Formulation Development & Analytical
- API Development & Pre-Clinical Batches
- Manufacturing of Drug Substance
- Manufacturing of Drug Product
- Quality Assurance Services
- Regulatory Services
- Clinical Pharmacology & CRO Management
- Other Services
- Accurate assessment of schedules and costs
- Accurate assessment of schedules and costs
"Activity Breakdown Structure" example from PathfINDAr™
Used in combination with a panel of PharmaDirections’ veteran pharmaceutical experts, PathfINDAr™ is a revolutionary interactive and real-time tool that anticipates the complexity of a drug development program to reduce errors, surprises and changes along the IND and NDA journey. PharmaDirections will work in conjunction with you to build this path together by assessing your program goals, then skillfully working though the questions and prompts in PathfINDAr™. This process keeps you intimately involved in the program planning and it ensures that no tasks are omitted or forgotten. Detailed plans are generated with visibility into the tasks and costs that provide an unprecedented level of confidence in the planning process.