Health Canada has announced December 14, 2022, as the new date for when the Canadian Food Inspection Agency’s (CFIA) updated food labelling regulations (which came into effect on December 14, […] Read More >>
You have probably heard of the terms IND and NDA being used during drug development and applications. People tend to get confused between the two terms and wonder how they […] 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 >>
During the pandemic of respiratory disease caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or Coronavirus Disease 2019 (COVID-19), the FDA Commissioner may authorize the use […] Read More >>
COVID-19 tests are considered medical devices and are regulated under the Medical Devices Regulations in Canada. Medical devices are classified into 4 classes: Class I are those with the lowest […] Read More >>
In 2000, a group of professionals from the food industry gathered with the goal of collaborating and finding solutions for the food industry challenges, most notably to reduce food safety […] Read More >>
Regardless of whether you are developing a new food or dietary supplement/natural health product (NHP) that you intend to sell in either the United States, or Canada, you must follow […] Read More >>
Clinical research in Canada has seen a significant uptick in interest from Sponsors and Investigators since the onset of the COVID-19 pandemic. This interest is perhaps a precipitate of increasing […] Read More >>
dicentra Global Certifications (dicentra GC), an American National Standards Institute (ANSI) ISO 17065 dicentra is pleased to have successfully received a Safe Food for Canadians Regulations Licence (SFCR) from the […] Read More >>
dicentra is pleased to have successfully received a Safe Food for Canadians Regulations Licence (SFCR) from the Canadian Food Inspection Agency (CFIA). A valid SFCR licence is required for importers and […] Read More >>
Health Canada has recently notified the industry that TMAL (Temporary Marketing Authorization Letter) holders for supplemented foods (and caffeinated energy drinks) which are set to expire on December 31, 2021, […] Read More >>
dicentra, a contract research organization (CRO) and professional consulting firm headquartered in Toronto, is proud to announce its partnership with AIDP Inc., who will be signing on as the exclusive […] Read More >>
dicentra, a contract research organization (CRO) and professional consulting firm headquartered in Toronto, is proud to announce its partnership with AIDP Inc., who will be signing on as the exclusive […] Read More >>
If you are currently using a COVID-19 Site Licence to manufacture, package, label, or import alcohol-based hand sanitizers, your licence will expire September 30, 2021. Background In August of 2020, […] Read More >>
Are you interested in an exciting and rewarding career in one of our four business divisions? Are you a highly-skilled technical professional who excels in providing clients with high-quality products […] Read More >>
On July 16, 2021, Health Canada issued a Notice to Interested Parties about a Proposal to amend the Cosmetic Regulations.According to the notice, the Proposal is open to pre-consultation from […] Read More >>
A clinical trial protocol is a document that is designed to outline all details of a clinical trial. It is the main document referred to throughout the trial lifecycle and […] Read More >>
In May of 2021, Health Canada announced a proposal to modernize the regulatory framework for Clinical Trials. This proposal hopes to help improve support the introduction of novel safe and […] Read More >>
Within a business, the organizational work culture integrates larger groups of people, not individuals alone, and this reflects on how these groups interact and behave. Food businesses are no different, […] Read More >>
N-acetyl-L-cysteine (NAC) is an amino acid that was approved by the FDA as a drug in 1963. Its primary uses as a drug include relieving symptoms of respiratory ailments as […] Read More >>