Rachelle D'Souza

Rachelle D'Souza

Rachelle D’Souza, CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up companies.

Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety / pharmacovigilance and medical information systems.

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets.

  • FDA Health Canada Rachelle DSouza Compliance Trainings
    This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization. The Food and Drug Administration...
  • FDA Regulation 3D Printing Medical Devices Rachelle DSouza Compliance Trainings
    The Food and Drug Administration (FDA) is responsible for the approval of medical devices in the United States of America. Today 3D printing is used in a wide variety of applications, even for the manufacture of medical devices. So...
  • FDA Health Canada Rachelle DSouza Compliance Trainings
    This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization. The Food and Drug Administration...