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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Update on Health Canada Risk Evaluation of N-nitrosamine Impurities in Canadian Human Pharmaceutical, Biological and Radiopharmaceutical Products

Apr 29, 2021

The deadline for the first step of Health Canada’s risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products was March 31, 2021. This deadline applied to Market Authorization Holders...

Tighter Restrictions to be implemented for Talc

Apr 29, 2021

The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA) to determine whether they present or may present a risk to human health or to the environment. A final risk assessment was recently completed...

FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021

Mar 29, 2021

In March 2020, provisions were added to the Federal Food, Drug, and Cosmetic Act by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which authorize FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters...

Phase I of the Self-Care Framework

Mar 12, 2021

Health Canada has announced that there will be updates to the approach to regulating self-care products as part of their 2020-2022 Forward Regulatory Plan. The self-care framework will roll out in phases over the coming years: Phase I – Target Spring 2021 will include...

Changes to INCI Names for Hydrocarbons

Mar 12, 2021

The international nomenclature for hydrocarbon ingredients currently designated by INCI names containing the stem terms ‘isoparaffin’ and ‘pareth’ will be revised. ‘Isoalkane’ and ‘alketh’ will replace these terms, respectively, preceded by the appropriate carbon...

Health Canada Risk Evaluation of N-nitrosamine Impurities: First Step Deadline Fast Approaching

Mar 7, 2021

The deadline for the first step of Health Canada’s new risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products is fast approaching. This new Health Canada requirement for all Market...

Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2)

Mar 7, 2021

IO No. 2 repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (IO No. 1) made by the Minister on March 30, 2020 and approved by the Governor in Council (GIC) on April 8, 2020. It...

Extension of Period of Validity for Site Licenses

Mar 7, 2021

If you have a Site License set to expire by March 31, 2021, the NNHPD is providing an extension for the site license period of validity until June 01, 2021. This is due to license renewal delays resulting from the COVID-19 pandemic. The extension is applicable to...

Face Masks – Innovation and Opportunity

Feb 5, 2021

It is hard to imagine that just one year ago we were shopping and eating in restaurants without fear and without face coverings. Since then, the use of facemasks and face shields has become commonplace even to the point that we feel naked without them when out in...

Interferon Beta 1a: Potentially Promising Treatment for Covid-19

Jan 20, 2021

A recent clinical trial reported in The Lancet Respiratory Medicine shows that the protein Interferon Beta 1a when inhaled, reduces the chances of hospitalized early-stage Covid-19 patients becoming severely ill or dying. The investigators conducted a randomized,...

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Delsie Braganza

Jennifer Porter, BA Psychology, MBA – President & CEO

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If you would like to be added to our newsletter, please send an email to mail@focalpointresearch.net with the subject line ‘Receive FPR Newsletter’.

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