Give us a product and we can help craft a strategy for the US only or on a global basis. Strategic services include:
- Construct global regulatory strategy including:
- Research appropriate end-points that are acceptable for different countries
- Research past precedence for development of regulatory strategy
- Therapeutic Area Analysis
- Conduct Gap Analysis for NDA approvability or IND acceptability
- Create Regulatory Development Plans
- Create Draft Package Insert or Target Product Profiles
- Meet with regulators to negotiate clinical end-points and other program needs (formally and informally)
- Manage project from conception through NDA approval
- Perform Competitor Analysis
- Perform/Prepare information for Due Diligence
To request our services, please fill out a Strategy Request Form (coming soon) or a Commenting Request Form (coming soon) and send to: ask@regulatorium.com.