Strategic Plans
PharmaDirections is a pharmaceutical consulting and project management firm that supports biotech and pharmaceutical companies with planning, oversight, and execution of the preclinical, CMC and regulatory aspects of the drug product development. To serve the needs of its clientele who are often in need of strategic planning and consulting, it invented and developed an expert system for planning called PathfINDAr (building a path to the IND and NDA). This is system that allows a rapid and complete translation to a Gantt chart that has durations, timing and costs. Among other things, this system allows PharmaDirections’ staff to draw on the skills of their 150 associates to design programs that start at lead optimization and conclude when drug products are ready for Phase 3 human clinical trials or for commercial sale.
The steps involved in strategic planning lead to a finished report that includes:
- Information Review
- Gap Analysis and planning using PathfINDAr
- Clinical Strategy and Narrative
- Preclinical Strategy and Narrative
- CMC Strategy and Narrative
- Regulatory Strategy and Narrative
- Pricing and Timeline