Services

Foods and Beverages

Foods are part of our daily life. Our team can review your foods, beverage and functional foods, to ensure they are shelf ready and compliant. Let us help you with getting your food products off the shelf and into shopping baskets.

  • Formulation and Ingredient reviews
  • Identifying the best nutritional, health & supporting (related) claims
  • Compliance liaison with FSANZ and State Health Departments
  • Guidance on your promotional materials, including websites, media advertising, labelling and packaging
  • Systematic reviews to support health claims
  • Consultation responses
  • Prepare applications to Government agencies
  • Nutritional Information Panel development and reviews to meet current standards
  • Guidance on specific standards of the Foods Standards Code, including Formulated Supplementary Sports Foods, Infant Formula’s and Formulated Meal Replacements

We can help with medicines including Listed, Complementary, Over the Counter, Dietary supplements, and Sunscreens, guiding your compliance with The Therapeutic Goods Act 1989. Our expert advice will help to ensure your products are compliant and bursting with the best achievable claims, whether on shelf or online. Let us help you with the following;

  • Ingredient/Formulation, product specification, label, advertising/promotional reviews and guidance
  • Claims and Evidence packages for therapeutic indications
  • Good Manufacturing Practice (GMP) preclearance for overseas manufacturers
  • Manufacturing advice and preparation for Good Manufacturing Practice (GMP) inspections and audits (domestic and international)
  • Preparation and submission of applications to Government agencies
  • Stability advice and protocol development
  • Compliance liaison with the TGA Section 31 and requests for further information
  • Pharmacovigilance and product centric post-market vigilance

Therapeutics

Personal Care

Products that we use on our faces, bodies, and in our homes, require the same attention as those we put into our bodies. Our team are passionate about your health & beauty and personal care products being the best they can be. Our services cover;

  • Formulation reviews for compliance with guidelines
  • Search for suitable information to support your product’s claims
  • Guidance and reviews on promotional materials, including websites, labelling and packaging, media advertising
  • Guidance on the grey area between cosmetic and therapeutic goods
  • Applications to Government agencies, including AICIS administration
  • Advice related to Sunscreens
  • Guidance on Over The Counter (OTC) medicines
  • Ingredient notifications
  • Cosmetic claims
  • Labelling requirements
  • Consultation responses
  • Government agency liaison

All Quality Systems are not created equal, this is why we create QMS design and management solutions which are bespoke, and auditing solutions that are tailored for your organisational needs. We can design and manage;

  • Quality management systems (QMS)
  • GMP/GLP/ISO9001
  • Adverse events assessments
  • Internal and external auditing
  • GMP and technical agreement reviews
  • Batch release recommendations
  • Complaint handling
  • Product quality reviews
  • Recall management, communication and support
  • Vendor qualification
  • Documentation (e.g. Specifications, SOPs)
  • Regulatory and Notified Body audit facilitation
  • Training in Quality and Systems

Quality Systems

Import and Export

Whether you need to bring products in, or send products out, we can help you navigate the sometimes tricky area of customs and excise.

  • Export advice and support
  • Import compliance advice and permits for new and established international products
  • Compliance requirements for NZ Dietary and Supplemented foods
  • Preparation of applications to Government agencies
  • Import and export licenses