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Natural health products (NHPs) include any substance or combination of substances including plants, plant materials, algae, bacteria, fungi, non-human animal material, their extracts, isolates, synthetic duplicates, vitamins, amino acids, essential fatty acids and their synthetic duplicates or minerals and probiotics that are either to diagnose, treat, mitigate a disease, disorder,............ Read More

Computer system validation (CSV) is the process of providing a high degree of assurance through documented evidence that a computer system consistently meets its pre-determined or intended use or quality attributes such as accuracy, security, reliability, and functionality. A computerized system can include hardware, software, its peripherals, interfaces, equipment, users............ Read More

Navigating through Canadian Drug Regulatory Processes AXSource Consulting Inc. helps its client manufacturers navigate through all the hurdles in the drug regulatory process. These usually include initial product classification, coordinating with Health Canada and consulting with drug manufacturers for successful market authorization, management of Health Canada regulatory filings for pre-market............ Read More

Pharmaceutical companies must comply with Pharmacovigilance (PV) regulations throughout the duration of product development and post-marketing product lifecycle. Some of the challenges the industry faces includes: keeping pharmacovigilance staff, maintaining drug safety monitoring and being compliant with regulatory requirements. What are the Pharmacovigilance Requirements? Pharmacovigilance is defined as the “science............ Read More

The global landscape of health is dynamic and ever competitive, especially when it comes to life sciences. As the year 2016 has just started, we are analyzing the imperative shift in the trends of the market, cities and service lines for life sciences (as witnessed in the previous year 2015)............. Read More

Electronic cigarettes, also known as e-cigarettes, consist of a battery-powered delivery system to heat or vaporize “e-liquid” or “e-juice,” a liquid chemical mixture comprised of nicotine, propylene glycol, flavor and other chemicals into an aerosol that is inhaled by the user. This is referred to as “vaping’. In recent months,............ Read More

Plain language is a clear writing style designed to be easy to read and understood by the intended audience. The plain language initiative of Health Canada is intended to ensure that information on labels can be easily understood by the target audience. Health Canada will evaluate plain language for drugs............ Read More

Compounded drugs made using poor quality practices may be sub- or super‑potent, contaminated, or otherwise adulterated. While compounding under poor quality practices has been previously associated with adverse events, the compounding industry remained opposed to Food & Drug Association (FDA) regulatory oversight on compounding drug practices (1). It was the............ Read More