GMP & ISO 22000 Certified Manufacturing β€” European Standards, Global Reach
Services / Regulatory

Regulatory Support
EU. UK. US. Global.

Our regulatory affairs team ensures your products meet all legal requirements in every target market β€” from EU notification to US DSHEA compliance.

Regulatory Services

Product Dossier Preparation

Complete technical files including formulation specifications, stability data, safety assessments, and manufacturing documentation.

Safety Assessment

Toxicological safety assessment by qualified assessors to EU Regulation 1223/2009 and food safety standards.

Ingredient Compliance

Full review of all ingredients against EU positive lists, novel food regulations, and maximum permitted levels.

Market Entry Strategy

Country-specific regulatory pathway analysis and timeline planning for new market launches.

Market Coverage

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European Union

  • EU Food Supplement Notification (all 27 member states)
  • EFSA health claim compliance
  • Novel Food assessment
  • EU Regulation 1169/2011 label compliance
  • REACH compliance for ingredients
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United Kingdom

  • UK Food Supplement Notification (FSA)
  • Post-Brexit labelling compliance
  • UK health claim review
  • MHRA borderline product assessment
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United States

  • FDA DSHEA compliance review
  • NDI (New Dietary Ingredient) assessment
  • cGMP documentation support
  • Structure/function claim review
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Middle East & GCC

  • UAE MOIAT registration support
  • Saudi SFDA documentation
  • Halal certification guidance
  • GCC import documentation

Speak to Our Regulatory Team

We provide a free initial regulatory assessment for all new partners.