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Delsie Braganza

Delsie joined the Focal Point Research team in 2011 and has been an invaluable asset for our clients. With her strong regulatory and quality assurance background, she is able to help clients understand the Canadian and US requirements, set targets to achieve compliance, and attain their goals to get products to market.

Delsie is able to audit facilities, set up and maintain GMP compliant facilities, develop strong quality management systems, and co-ordinate successful Health Canada inspections. In addition to this, Delsie oversees all regulatory compliance reviews and submissions made to Health Canada and the US FDA.

Delsie obtained an Honours Bachelor of Science (Hons. B. Sc.) in Pharmaceutical Chemistry from the University of Toronto, Post-Graduate Certificate in Pharmaceutical Regulatory Affairs and Quality Operations (RAQ) from Seneca College and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).

When she’s not learning something new, Delsie loves spending time with family, going on road trips or long walks, and swimming.

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Robert Fichtner

Since co-founding Focal Point over 20 years ago, Rob has led our Regulatory and Scientific practice. A chemist by training, his experience includes Cosmetics, Drugs, Medical Devices, Consumer Products and Natural Health Products (Dietary Supplements). Rob has participated in the launch of thousands of products including their formulation, manufacturing and regulatory submissions for approval. His wealth of experience spans almost 40 years in innovation.
Rob has been involved in all aspects of innovation and new product development. He shares some of his insights in his new video series “Lectures in Innovation”. You can view the first video here.
When not supporting innovators, Rob spends his time becoming a better sailor and guitar player.

(905) 271 2709 mail@focalpointresearch.net
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Summary Reports and Issue-related Analysis Reports

Summary Reports and Issue-related Analysis Reports

by Srishti Chaudhari | Nov 30, 2023 | Canadian Quality Assurance, Canadian Regulatory, Medical Devices

A Periodic Summary Reports is a comprehensive assessment of new information on the benefits and risks of a licensed Class II, III or IV medical device. Summary Reports are required by Health Canada for all medical devices. The reporting timeline for medical device...
Medical Device Incident reporting

Medical Device Incident reporting

by Srishti Chaudhari | Nov 30, 2023 | Canadian Quality Assurance, Canadian Regulatory, Medical Devices

Health Canada requires the manufacturer and importer to submit both a preliminary and a final mandatory report constituting the details of any incident relating to the failure of a medical device or any inadequacy in its labelling or in its directions for use...
Foreign Risk Notification (FRN)

Foreign Risk Notification (FRN)

by Srishti Chaudhari | Nov 30, 2023 | Canadian Quality Assurance, Canadian Regulatory, Medical Devices

Health Canada intends to improve the collection and assessment of new information relevant to the safety of a medical device in certain foreign jurisdictions to help determine an appropriate response in Canada to any risks reported. Per the Foreign Risk Notification...
Health Canada Monograph Revisions Coming Soon!

Health Canada Monograph Revisions Coming Soon!

by Sagarika Sharma | Nov 6, 2023 | Canadian Regulatory, Natural Health Products

The Natural Non-Prescription Health Products Directorate (NNHPD) has an important update – they will begin revising all NHP monographs. The primary objective of the monograph revision initiative is to modernize the NHP monographs, ensuring they meet the new NHP...
California Expands Cosmetic Safety Regulations with AB 496

California Expands Cosmetic Safety Regulations with AB 496

by Srishti Chaudhari | Nov 6, 2023 | California Cosmetic Regulations, Cosmetics, U.S. Regulatory

In a move to bolster consumer safety, California is enhancing its regulations governing cosmetics with the introduction of Assembly Bill 496 (AB 496). This law updates the state’s 2020 Toxic-Free Cosmetics Act, which initially banned 24 chemicals from use in personal...

Recent Posts

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  • Update: Final Amendments to the Charter of the French Language regulations published today
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