Case Studies

Case study
One

Full Support for Launching a Food Supplement onto an EU Market

Client Context

  • Mid-size food supplement company planning EU market entry
  • Limited in-house EU regulatory experience
  • Tight timelines and multiple SKUs

Challenge

  • Navigating EU Food Supplements Directive requirements
  • Understanding FBO responsibilities
  • Ensuring compliant formulation, labelling, and market readiness across target Member States

Our Support

  • Confirmed ERU/FBO roles and responsibilities for EU market placement
  • Gap analysis against relevant harmonised EU and national legislation
  • Regulatory strategy for market entry (single vs multi-country approach)
  • Ingredient compliance checks (vitamins, minerals, botanicals, novel food considerations)
  • Label review and compliance remediation (mandatory particulars, claims interface, language requirements)
  • Notification requirements and Member State nuances
  • Ongoing ERU support model post-launch (change control, vigilance, challenges)

Outcome

  • Successful EU market launch within agreed timelines
  • Clear internal ownership of ERU responsibilities
  • Reduced regulatory risk and improved confidence with competent authorities
Case study
Two
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