Ms. Rachelle D’Souza

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Profile

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.

 

7 results Found
Recorded Webinar

Cosmetic Testing for US FDA Compliance

The US Food and Drug Administration (FDA) holds cosmetic manufacturers and distributors responsible for the safety and quality of their cosmetics. This webinar serves to guide cosmetic manufacturers and distributors as well as other entities such ...

  • Intermediate
  • 60 Mins
Recorded Webinar

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

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.  

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Cosmetic Testing for US FDA Compliance

The US Food and Drug Administration (FDA) holds cosmetic manufacturers and distributors responsible for the safety and quality of their cosmetics. This webinar serves to guide cosmetic manufacturers and distributors as well as other entities such ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

Drug Pharmacy Compounding

This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Cosmetic Testing for US FDA Compliance

The US Food and Drug Administration (FDA) holds cosmetic manufacturers and distributors responsible for the safety and quality of their cosmetics. This webinar serves to guide cosmetic manufacturers and distributors as well as other entities such ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

FDA vs Health Canada 2017

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.

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Cosmetic Testing for US FDA Compliance

The US Food and Drug Administration (FDA) holds cosmetic manufacturers and distributors responsible for the safety and quality of their cosmetics. This webinar serves to guide cosmetic manufacturers and distributors as well as other entities such ...

  • Intermediate
  • 60 Mins