If you plan to sell cosmetics in Canada, one of the first compliance steps is completing Health Canada’s Cosmetic Notification Form (CNF). This form is an essential regulatory requirement under […] The post Understanding Health Canada’s Cosmetic Notification Form: What You Need to Know appeared first on dicentra.| dicentra
FDA has banned Red 3 for foods & ingestible drugs. Learn the impact, compliance dates, and petition steps for ingredient companies.| dicentra
Misusing HS-Codes can lead to delays, tariffs, or penalties. Learn how to classify foods, NHPs, and drugs correctly for import into Canada.| dicentra
Learn the rules for using “Made in Canada” or “Product of Canada” on your labels. Stay compliant with CFIA and Competition Bureau guidance.| dicentra
dicentra's expert helps your company navigate the complex NDI Notification submission process. Learn how our team can help.| dicentra
Access expert FDA regulatory support for Medical Device 510(k) and PMA submissions in the United States. Contact dicentra today!| dicentra
Generally Recognized as Safe (GRAS) Consulting: Expert guidance for FDA GRAS & Self-Affirmations. 100% success rate. 22+ years of experience.| dicentra
Our dietary supplement label review service will help you ensure the dietary supplement you import or sell in the USA is compliant with applicable FDA rules. We identify and correct any mistakes or enforcement risks before you print or ship your products| dicentra
Planning and review at each stage of the development process is necessary to ensure that your personal care products will receive prompt acceptance| dicentra
FDA tools Elsa and CDRH-GPT mark a shift in oversight. Learn how AI could impact GRAS, NDI, and device reviews and how to be submission-ready| dicentra
Explore the differences between Risk-Based Monitoring (RBM) and 100% Source Data Verification (SDV) for clinical trials| dicentra
Learn what a Clinical Research Feasibility Assessment (CRFA) is and how it helps sponsors plan, evaluate, and de-risk clinical trials.| dicentra
Is eliminating self-affirmed GRAS the answer? Kennedy thinks so—dicentra explores what this means for FDA oversight and food safety.| dicentra
Health Canada has launched a consultation on a proposed regulatory pathway for health products containing cannabidiol (CBD) that would allow access without a prescription. This marks a significant step in […] The post Health Canada Consultation: Proposed Regulatory Pathway for Non-Prescription CBD Products appeared first on dicentra.| dicentra
Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) has announced a major shift in how Class III Natural Health Product (NHP) submissions will be reviewed. As of March 5, […] The post New Prioritization for Class III NHP Submissions: What You Need to Know appeared first on dicentra.| dicentra