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.

Jennifer Porter, BA Psychology, MBA – President & CEO

Having started at Focal Point Research in 2011, Jenn has been fully engaged in the company and since day one, has leveraged her MBA and interest in the regulated products industries to grow her passion for the business and services offered.

Jenn has excelled at building on initial conversations with a variety of companies from all industries seeking regulatory and quality assurance services. She has developed strong relationships with each client, offering each one a unique opportunity to have the Focal Point Research team help them develop successful strategies and bring products to market, while ensuring their compliance needs are being fulfilled.

Jenn has not only been a leader internally, but a key contact for all clients and in 2021, Jenn was the obvious choice to lead Focal Point Research into the future as the successor to company founder, Rob Fichtner.

Jennifer balances her career by honouring her wanderlust, spending her leisure time golfing, and enjoying the outdoors with her loving dog.

Medical Devices

Medical Device Consulting Services in Canada

Focal Point Research provides exceptional professional services that will enable medical device companies from different parts of the world to gain unhindered entry into the Canadian market. We offer understandable technical advice to help ensure Health Canada regulatory and quality system compliance is achieved for all classes of medical devices.

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View Consulting Services

Focal Point Research offers the following
Medical Device Consulting Services

Regulatory Affairs

Canadian Label Reviews
Advertising & Promotional Reviews
Medical device submissions to Health Canada (MDL)
Applications for revisions to and maintenance of Medical Device Establishment Licenses (MDEL)

Quality Assurance

Hosting Health Canada MDEL inspections
Writing and maintenance of SOPs
Recalls – Section 64, Section 64 Submissions

MEDICAL DEVICES – Post-Market Surveillance

Establish and implement procedures to receive, analyze, submit and maintain Adverse Event (AE) records and/or Incident reports
Reporting of incidents to Health Canada
Assisting with implementation of corrective actions following an incident occurrence

“Focal Point Research has consistently and professionally looked after regulatory and quality issues of our brand for years. Through a courteous and knowledgeable team, they have managed to navigate us through an ever changing regulatory landscape while maintaining our interests, and allowed us to correctly distribute and sell within Canada.”

“I have truly enjoyed working with you over the last 8 years! You and your team have been an amazing resource for me. I have always been impressed by the knowledge and professionalism of everyone at Focal Point, which is a true testament to your leadership.”

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The Focal Point Research team is ready to help with all of your scientific and regulatory needs. Our team has the experience and expertise you need to see your product to market and we are eager to help you.

181 Lakeshore Road E. Mississauga, ON

1 (905) 271 2709

mail@focalpointresearch.net

Delsie Braganza

Jennifer Porter, BA Psychology, MBA – President & CEO

Medical Devices

Medical Device Consulting Services in Canada

Focal Point Research offers the following Medical Device Consulting Services

Regulatory Affairs

Quality Assurance

MEDICAL DEVICES – Post-Market Surveillance

Connect With Us

Focal Point Research offers the following
Medical Device Consulting Services