Marketing Applications

You have conducted pivotal studies and have met your study endpoints and are moving toward filing a marketing application such as a New Drug Application, Biologics Licensing Application or Marketing Authorization Application.

Let MVG Consulting help you with this process and get sites and vendors ready for regulatory agency inspections.

• Preparation of Common Technical Document sections
  • Preclinical
  • CMC
  • Clinical
• Assessment of inspection readiness for sites and vendors
• Inspection Readiness Training
• Mock inspections at sponsor, sites and vendors
• Planning post-marketing commitment studies