Strategic Planning

Pharmaceutical development is an exceptionally complex process. Successful pharmaceutical development is dependent upon having an appropriate and detailed strategic plan. Any strategic plan by definition, should ensure the organization is operating efficiently by determining it's current viability, future directions, as well as how to proceed to achieve the aims or goals of the organization. It should, of necessity, address the allocation of human and financial resources in achieving the desired direction. In very simple terms, the strategic plan may be likened to a roadmap, showing a starting point, an end point as well as instructions on how to move forward.

You are far more likely to be successful when you have a detailed strategic plan of tasks, costs, and timing to work with. PharmaDirections has developed a proprietary strategic planning system called PathfINDAr™ which we use to help our clients chart a path from lead identification through INDs and proof-of-concept studies and onward toward their NDAs and BLAs.

To suit our clients’ needs, we generate strategic plans with various levels of detail, from "30,000 foot" overviews for presentation to venture capitalists to multi-tiered Gantt charts with hundreds of detailed tasks ready to be executed by our project managers. Our plans can be tailored to a specific goal or can incorporate all aspects of development, including:

• Drug Discovery
• API process development
• Preclinical pharmacology and toxicology studies
• Formulation development
• Drug substance and drug product GMP manufacturing
• Regulatory submissions