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Regulatorium
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Strategy

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.