Blog

Biocide Task Force: how to make your Regulatory Life easy
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Biocide task forces are collaborative industry groups formed to bring together companies in the registration...
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March Regulatory Updates
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Biocides: UK-EU SPS Alignment for PPPS & Biocides The new UK-EU SPS Agreement (targeted for...
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Extractable and Leachables material composition and supply chain for ICH Q3E compliance
ICH Q3E: E&L risks with Material Variability and Supply Chain
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ICH Q3E places strong emphasis on understanding and controlling extractables and leachables (E&L) risks throughout...
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USP Class VI
USP Class VI: New Approach to Polymer Safety in Medical Devices
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For decades, many medical device manufacturers have relied on USP Class VI certification when selecting...
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Food supplement products can be novel or non-novel food, regardless of its ingredient.
Novel Food in Ingredients and Food Supplements: Key Differences
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Did you know that in the EU an ingredient can be classified as a Novel...
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Regulation (EU) 2026/405 shifts detergents compliance into...
Regulation EU 2026/405: New Detergents and Surfactants Compliance
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Regulation (EU) 2026/405 is the new European Union regulation on detergents and surfactants, published in...
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February Regulatory Updates
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Biocides: BPC approves Ethanol use for disinfectants and hand sanitizers On February 24 in Helsinki,...
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Permitted Daily Exposure
Permitted Daily Exposure within EMA and ICH Framework
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Permitted Daily Exposure (PDE, also referred to as “permissible daily exposure”) is a health-based limit...
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Mandatory EUDAMED: What changes from May 2026
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EUDAMED will become mandatory from May 2026. The European Database on Medical Devices, a key...
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PFAS: Compliance of the “Forever Chemicals”
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What are PFAS?  The large family of synthetic substances is characterized by the presence of...
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