Rachelle D'Souza
CEO & President of Regulatory Heights Inc.
Rachelle D'Souza has licensed various medical and consumer products and facilities for start-ups and multi-national 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 like Canada, USA, EU, China, Japan, Australia and New Zealand.
Upcoming Webinar
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Recorded Webinar
Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations
Did you know that Electronic Health Record (EHR) can be used in prospective clinical investigations of human drugs, biologics, medical devices and combination products regulated by the US Food and Drug Administration (FDA)? This includes foreign studies used in support of an application for marketing approval of the medical product. 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. A refresher on key requirements for Computer Systems used in Clinical Investigations is also included.
Recorded Session Get life time access for one participant with download option!

FDA Regulation on 3D Printing and Medical Devices
This 90-minute webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices. As technological advancements continue to permeate the medical device world, few hold more promise than 3-D printing. Everything from prosthetics to organs have been (or can be, theoretically) "printed." Thus, the opportunity presented has intrigued device firms because of increased product efficacy, manufacturing benefits, and other advantages. Now that the guidance 'Technical Considerations for Additive Manufactured Devices' (May, 2016) has been finalized, many questions have been answered but several remain. What does this guidance mean? How do I enter the market? What are the considerations regarding scale-up for manufacturing of product?
Recorded Session Get life time access for one participant with download option!

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 as color additive manufacturers and analytical and microbiological laboratories on FDA recommendations and requirements concerning the safety and quality testing of cosmetics. Topic areas covered in this webinar include, FDA considerations for microbiological testing, animal testing, potential contaminants, nanomaterials in cosmetics, cosmetic good manufacturing practices (GMP) compliance testing, shelf life/expiration dating, select cosmetic ingredients and color additive batch certification.
Recorded Session Get life time access for one participant with download option!

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