Other than the tax code, is there any more complex, confusing and shifting set of rules than those governing drug development? Knowledge of regulatory affairs is purely experiential; it can’t be learned in a book. It comes from being at ODAC meetings when precedents are set, from unexpected successes, and  yes, even from failures. It is the understanding that regulatory affairs is a delicate negotiation requiring that elusive quality called judgment.  

  • Regulatory strategy
  • Clinical support/expertise for Pre-IND, End of Phase 2, Pre-NDA meetings
  • Assistance with IND annual reports
  • Assistance with Investigator Brochures
  • Integrated summaries