Drug Development and Regulation

VOI enhances development efforts and ensures regulatory compliance throughout the world.

Drug Development & Regulation

VOI Consulting works with large and small biopharmaceutical companies, as well as CROs, patient recruitment firms, and government agencies to enhance and expedite international drug development. VOI also helps clients navigate the complexities of international drug regulatory systems to get products approved, defend intellectual property rights, and maximize lifecycle value.

VOI’s drug development and regulatory services include:

  • Identification and assessment of licensing opportunities through academic-to-industry technology transfer.
  • Valuation of in-licensing and out-licensing opportunities.
  • Intellectual property strategies.
  • Selecting endpoints to improve probability of approval and market success.
  • Development of Target Product Profiles (TPPs).
  • Optimizing clinical trial site selection through analysis of epidemiologic, health system, and geodemographic factors 
  • Incorporation of ICH, FDA, EMA, and other regulatory standard practices into clinical trial design. 
  • Development of locally compliant patient recruitment efforts.
  • Reducing incidence of lost-to-follow-up patients.
  • Preparation of applications and other regulatory submissions for new, generic, and biologic agents.
  • Use of 505(b)(2), biosimilar, compassionate use, and other approval pathways.
  • Lifecycle extension via translation of off-label uses to supplemental indications and Rx-to-OTC switches.
  • Ensuring compliance of marketing efforts. 
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