Time to Renew: FDA Drug Establishment and Listing Deadline Is Coming Up
If your company manufactures, repacks, relabels, or imports drugs for distribution in the U.S., it’s time to prepare for the
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October 23, 2025
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[blog_list]
FY 2025 OMUFA Fees Due June 2: What You Need to Know
The FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a
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June 1, 2025
Health Canada electronic filing updates: Key changes in 2025
If your team handles drug product submissions in Canada, there’s a recent update from Health Canada you might want
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May 9, 2025
Health Canada’s NDS, SNDS, and ANDS Pathways: Which One Is Right for You?
If you’re thinking about bringing a pharmaceutical product to the Canadian market, getting familiar with drug submission pathways is a
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November 1, 2024
Good Manufacturing Practices GMP for pharmaceutical companies
Introduction: When it comes to the pharmaceutical industry, there is no room for error. The production of pharmaceuticals requires strict
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June 6, 2023
Key Strategies to Improve Drug Submission Success
In the pharmaceutical industry, proper drug submission management is crucial to the success of any drug development process. The submission
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May 16, 2023
Drug Identification Number (DIN) Unlocked Inside Scoop
Many drug industries are working in every country. To sell any OTC drug in Canada is not possible without
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September 29, 2022
Health Canada’s Regulatory Enrollment Process (REP): Top 4 things to know
Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
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September 9, 2022
Classifying Your Product: Drug, NHP, or Cosmetic?
Learning how to classify your product correctly is one of the most important first steps when entering the Canadian market.
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June 9, 2022
Top 6 Questions to ask about OTC Drugs
1. What are over-the-counter drug products (OTC drugs)? Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can
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April 25, 2022