Blog

Relevance and Quality of Ecotoxicological Data: Why is this Important in Risk Assessment? Why Use a Consistent Evaluation Approach?

For a risk assessment to be credible and objective, scientifically defensible data must be used. This means that the studies used to generate the data must be evaluated using a standardized evaluation method, regardless of whether the studies were conducted in accordance with Good Laboratory Practice (GLP). It is, therefore, essential to apply transparent and …

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Perfluoroalkyl Substances (PFAS) – What are they and how do they affect me?

Perfluoroalkyl Substances (PFAS) – What are they and how do they affect me? What are PFAS? Perfluoroalkyl substances (PFAS) represent a group of man-made fluorinated organic compounds that are highly stable and persistent in the environment. These compounds have been used in industrial applications and consumer products since the 1950s, and many different PFAS have …

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Risk Assessment and Traditional Food Consumption

Traditional foods play an important nutritional, social, cultural and economic role for Indigenous Peoples in Canada.  This is particularly true in isolated northern communities where access to store-bought, nutrient-rich foods may be limited due to a lack of availability, lower quality and/or high costs. Traditional food refers to those foods that are harvested from the local environment, …

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Planning to File Your 505(b)(2) Product in Canada?

Canada may not be top of the list of countries that companies target for first registration of their product (although it may be for orphan drugs – however, that’s a subject for another day!), but it’s usually in the next tier after USA and Europe, since typically Canada represents about 10% of the market size …

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FDA’s eCTD Mandate: Are You Ready?

When FDA posted their eCTD mandate last year, it was more of a whisper than a bang.  It certainly did not wreak havoc in the industry; after all, we were all warned that the time would come sooner rather than later. The deadlines are quite clear: After May 5, 2017 The following submission types must …

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