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.

Health Canada Consultants

Health Canada Consultants

Focal Point Research is a highly experienced Regulatory Affairs & Quality Assurance Consulting Firm. We have long been considered a leader in scientific and regulatory compliance across many industries and we maintain that reputation by remaining current with regulations and forecast changes that are expected. Whether you are creating a new product, or enhancing an existing one, we have the know-how to get your product to market.

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Focal Point Research offers the following
Health Canada Consulting Services

Canadian Agent for Cosmetics

Act as authorized representative for foreign companies
Complete Cosmetic Notification Forms
Correspond with Health Canada on your behalf
Hold all product related documents on file to fulfil Canadian requirements

Cosmetic Consulting

Review Labels, Inserts, and Advertising for Canadian Compliance
Review ingredients for Canadian compliance with our proprietary software
Prepare and Submit Health Canada Cosmetic Notifications
Design and commission product testing, clinical trials to establish claim support and product compatibly
Provide regulatory support for products refused entry by Canadian Customs and/or Health Canada inspectors

Natural Health Product (NHP) Consulting

Review Labels, Inserts, and Advertising for Canadian Compliance
Review ingredients for compliance with our proprietary software
Prepare and submit Product License Applications
Prepare and submit Site Licence Applications
Assistance with importation of Natural Health Products to Canada
Setup and implementation of NHP GMP Quality Assurance System

Drug Consulting

Review Labels, Inserts, and Advertising for Canadian Compliance
Review ingredients for compliance with our proprietary software
Prepare and submit applications to Health Canada for approval; DIN, CTA, NDS, ANDS
Drug Establishment License Approvals
Setup and implementation of Drug GMP Quality Management System

Medical Device Consulting

Label Reviews and Classification of Products, Class I to IV
Prepare and Submit Applications for Class II, III or IV
Obtain and maintain Medical Device Establishment Licenses
Host Health Canada MDEL Inspections

Medical Affairs and Adverse Effect Reporting

Preparation of medical documents for healthcare professionals
Analysis of adverse events for cosmetics, drugs, devices and supplements

Consumer Product Consulting

Review packaging and labelling for regulatory compliance
Evaluate consumer complaints and manufacturing quality systems

Packaging Development Consulting

Development of primary, secondary and tertiary packaging components
Label development, including review of labelling requirements for the Canadian market
Shelf life testing of package and product interactions using both analytical and sensory evaluation

“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.