Feasibility Studies
Objectives of Feasibility Studies:
1. Market Analysis:
- Assess the technical, financial, and operational feasibility of a project.
- Identify potential risks, challenges, and opportunities.
- Determine the project's alignment with business objectives and strategies.
- Provide a basis for informed decision-making.
- Market size and growth potential.
- Competitive landscape.
- Target patient population.
- Pricing and reimbursement strategies.
- Drug candidate's properties (e.g., stability, bioavailability).
- Formulation development.
- Manufacturing process scalability.
- Analytical method development.
- Regulatory requirements (e.g., FDA, EMA, ICH).
- Clinical trial design and execution.
- Approval pathways (e.g., fast track, orphan drug).
- Project costs (e.g., R&D, manufacturing, marketing).
- Funding options (e.g., investors, grants).
- Return on investment (ROI) analysis.
- Resource allocation (e.g., personnel, equipment).
- Supply chain management.
- Quality control and assurance.