On December 22, 2022, Health Canada opened consultation on a proposal to amend the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs). The […] Read More >>
In regulatory affairs, a dossier is a term used to describe a compilation and array of documents regarding the safety, efficacy, and quality information of a medical product. The dossier […] Read More >>
Between February and April of 2017, Health Canada inspectors visited 23 domestic Canadian Site Licence holders in order to assess their compliance with the Natural Health Product Good Manufacturing Practices. […] Read More >>
CHFA East 2019 has wrapped up another successful conference and trade show. From numerous educational sessions to new products at the tradeshow, there was a lot of great information and […] Read More >>
Clara di Tella, BSc, Pharm. QA Regulatory Affairs Specialist, dicentra Inc. On November 24, 2011 the European Food Safety Authority (EFSA), the Food and Agriculture Organization of the United Nations […] Read More >>
William Morkel, BSc Senior Quality Assurance and Regulatory Affairs Specialist, dicentra Inc. Under the current guidelines for Good Manufacturing Practices (GMPs) for Natural Health Products (NHPs), manufacturers and importers of […] Read More >>
Manushvi Chadha, BPharm, RA Cert Regulatory Affairs Associate, dicentra Inc. Nanomaterials are engineered molecules whose defining characteristic is their size – they range from 1-100 nanometers where each nano is […] Read More >>
Clara di Tella, BSc, Pharm QA Regulatory Affairs Specialist, Dicentra The United States Food and Drug Administration along with regulatory agencies from 80 other countries have completed the International Internet […] Read More >>
Ashleigh Hampton, MSc Scientific and Regulatory Affairs Associate, Dicentra There have been some challenges faced while assessing the therapeutic effects of resveratrol in humans. Phase 1 clinical trials have reported […] Read More >>
William Morkel, BSc Senior Quality Assurance and Regulatory Affairs Specialist, Dicentra From late September to mid October the NHPD will be holding information sessions in Montreal, Toronto, Vancouver, and Halifax […] Read More >>
Manushvi Chadha, BPharm, RA Cert Regulatory Associate, Dicentra The FDA recognizes that the production of FDA-regulated products has gone international, with more globalization on the way. Not only wholly manufactured […] Read More >>
Health Canada Update: Non-Medicinal Ingredient Labeling for Nonprescription Drug Products Clara di Tella, BSc, Pharm QA Regulatory Affairs Specialist Health Canada has released a notice to inform drug manufacturers/sponsors of […] Read More >>
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