• Development of Regulatory Strategies


  • Common Technical Document

  • Clinical Trial Applications/IND


  • Clinical/Preclinical Overviews


  • Clinical/Preclinical Summaries


  • Summary of Product Characteristics / Labeling


  • CMC


  • Variations to Applications


*New Service*

We now offer facilitated
sessions for the MeduMaZe
Drug Development & Approval Game
  • Plant Master Files &
    Drug Master Files


  • Responses to Deficiency Letters


  • Literature Summaries


  • Re-Registrations


  • Regulatory writing for submissions


  • Regulatory Affairs Tutorials


  • Assistance with other regulatory and medical writing needs

       What Can You Expect From Us?

      Personalized attention to your regulatory needs     Commitment to provide outstanding service    
      Firsthand Knowledge of world-wide regulatory issues    



Some companies we have provided services to:
  • Abbott Laboratories

  • Achillion Pharmaceuticals, Inc.
  • Atrix Laboratories, Inc.

  • Bayer Healthcare

  • The Dial Corporation

  • Eriochem S.A.

  • Gebauer Co.

  • G.D. Searle & Co.

  • Hospira, Inc.
  • Impax Pharmaceuticals, Inc.
  • Maxim Pharmaceuticals
  • Mayne Pharma

  • Medtronic, Inc.

  • Novartis Pharma AG

  • Revolutionary Business Concepts, Inc.

  • Takeda Pharmaceuticals North America

  • Tetrionics

  • Wm. Wrigley Jr. Co.