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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...
Proposed Fees for Natural Health Products

Proposed Fees for Natural Health Products

by Sagarika Sharma | Jun 27, 2023 | Canadian Quality Assurance, Canadian Regulatory, Importation of NHPs, Natural Health Products

Currently in Canada, there are no Health Canada fees charged in relation to Natural Health Products (NHPs). In May 2023, Health Canada proposed implementing cost recovery fees to enhance regulatory oversight and streamline the approval processes for NHPs. The proposed...
Maine PFAS Reporting Deadline Approaching

Maine PFAS Reporting Deadline Approaching

by Sagarika Sharma | Dec 8, 2022 | Cosmetics, OTC Drugs, U.S. Regulatory

Maine enacted a law in July 2021 requiring manufacturers of products containing intentionally added Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) to report to the Maine Department of Environmental Protection by January 1, 2023. Moreover, the sale of products...
Notice to Stakeholders concerning the Cosmetic Ingredient Hotlist

Notice to Stakeholders concerning the Cosmetic Ingredient Hotlist

by Sagarika Sharma | Nov 21, 2022 | Canadian Regulatory, Cosmetics

Health Canada is considering certain substances for inclusion in future updates to the Cosmetic Ingredient Hotlist (Hotlist). The proposal includes the following: Additions to the Hotlist Changes to the conditions for existing entries on the Hotlist Changes to include...
California Bill AB-2787 proposes to ban microplastics in leave-on products

California Bill AB-2787 proposes to ban microplastics in leave-on products

by Sagarika Sharma | Jul 4, 2022 | Cosmetics, U.S. Regulatory

In February 2022, the Assembly Bill 2787 was introduced. This Bill will ban the sale of specific products such as cosmetics, detergents, wax, polishes, etc., in California, if they contain intentionally added microplastics. Biodegradable and water-soluble materials...
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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 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 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.