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.
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...
This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products. Did you know that electronic health record (EHR) can be used in prospective clinical...