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EU Regulatory Insights
Regulatory updates, compliance guides, and EU market entry insights for supplement brands, cosmetic companies, and North American exporters.
A2LA vs UKAS vs COFRAC: Which Accreditation Body Is Right for You?
Comparing A2LA, UKAS, and COFRAC — the three most important laboratory accreditation bodies for manufacturers targeting US, UK, and EU markets. Which one do you need?
Canada Natural Health Products Regulations: What US Brands Need to Know
Health Canada's Natural Health Products Regulations require a Product Licence before selling supplements in Canada. How the NHP framework works and how to get licensed.
Cosmetic Product Safety Report (CPSR): Full Requirements Guide
What is a CPSR? Who needs one? What must it contain? A complete guide to the Cosmetic Product Safety Report required under EU Cosmetics Regulation 1223/2009.
CPNP Cosmetic Notification: Step-by-Step Registration Guide
How to notify a cosmetic product through the EU CPNP portal. Step-by-step guide covering registration, required information, common errors, and timelines.
Drug Development Consulting in Europe: From IND to Marketing Authorisation
The complete EU drug development pathway from pre-clinical through marketing authorisation. Timelines, regulatory milestones, and how consulting support accelerates the process.
DSHEA vs EU Food Supplement Directive: Key Regulatory Differences
DSHEA governs supplements in the USA; EU Directive 2002/46/EC governs them in Europe. The two frameworks differ fundamentally. Here is what manufacturers need to know.
EFSA Health Claims: How to Get Your Supplement Claim Approved
EFSA evaluates health claims for food supplements under Regulation (EC) No 1924/2006. How the process works, what evidence is required, and why most claims fail.
EU Clinical Trial Regulation (EU CTR): Complete Guide for Sponsors
The EU Clinical Trial Regulation (EU) No 536/2014 replaced the 2001 Directive. This guide covers what changed, CTIS submission, and what sponsors need to know for EU trials.
EU Cosmetics Regulation 1223/2009: Prohibited and Restricted Substances
EU Cosmetics Regulation (EC) No 1223/2009 Annex II lists 1,600+ prohibited substances. Annex III lists restricted ones. What manufacturers must know about both lists.
EU Market Entry Strategy for North American Brands: Step-by-Step
How North American supplement, cosmetic, and pharmaceutical brands should approach EU market entry. Strategy, regulatory pathway, timeline, and cost planning.
EU MDR Consulting: Medical Device Regulatory Requirements Explained
EU Medical Device Regulation (EU) 2017/745 replaced MDD in 2021. What manufacturers need to know about MDR compliance, Notified Bodies, and the transition timeline.
EU Novel Food Regulation: Which Supplement Ingredients Are Affected?
EU Novel Food Regulation (EU) 2015/2283 applies to supplement ingredients not consumed in the EU before May 1997. Which ingredients need authorisation and how to get it.
EU Responsible Person for Cosmetics: Full Legal Obligations
What is an EU Responsible Person for cosmetics? What are their legal obligations under Regulation 1223/2009? Who needs one and how to appoint them correctly.
EU Supplement Labeling Requirements: Vitamins, Minerals & Botanicals
What must appear on EU food supplement labels? Requirements under Directive 2002/46/EC and Regulation (EU) 1169/2011, including NRVs, warnings, and botanical-specific rules.
Exporting Supplements from USA to EU: Complete Compliance Guide
How to export dietary supplements from the USA to the EU. Regulatory requirements, ingredient compliance, labeling, CPNP notification, and market entry strategy.
FDA 21 CFR Part 111: GMP Requirements for Dietary Supplement Manufacturers
21 CFR Part 111 sets GMP requirements for dietary supplement manufacturers in the USA. What it requires, how FDA enforces it, and how it compares to EU GMP standards.
GMP Audit Preparation: What EU Inspectors Look For
How to prepare for a GMP audit by EU regulatory inspectors. What ANSM, EMA, and national authority inspectors examine, common findings, and how to avoid them.
How to Find and Verify an ISO 17025 Accredited Laboratory
How to find ISO 17025 accredited laboratories, verify their accreditation scope, and avoid common mistakes when selecting a contract testing laboratory for regulatory submissions.
