Expedite Your FDA Generic Drug Approval


Expedite Your FDA
Generic Drug Approval:
Deliver Flawless
ANDAs the First Time

Your office, July 15, 2014

Who will benefit

Pharmaceutical companies and professionals looking to understand today’s increased US regulatory requirements for generic drug approvals in the US, the impact of the recent approval of GDUFA, and how to avoid deficiencies in your pivotal ANDA submission, particularly regarding the Quality and Bioavailability/Bioequivalence requirements. Including:

  • Submission and applications specialists
  • Strategic planning and lifecycle management specialists
  • Executive management
  • General/corporate counsel
  • Personnel new to the industry
  • Regulatory professionals
  • Consultants/service providers