Services

  • Preparation of high-quality registration submissions for new products, new chemical entities, new Listable substances, generics, restricted representations, exemptions, manufacturer’s evidence
  • Changes to existing ingredients and products
  • Non-standard submissions including priority review, provisional approval, orphan drug designation, comparable overseas regulators applications
  • Carrying out negotiations necessary to obtain or maintain marketing authorisation
  • Amendments to the Poisons Standard (scheduling submissions)
  • Preparation and lodgement of Product Information (PI) and Consumer Medicines Information (CMI)
  • Evaluation of advertising
  • Preparation and review of evidence packages
  • Label and package insert preparation and review
  • Clinical trial/stability trial protocol evaluation
  • Liaison and pre-submission meetings with TGA, Medsafe
  • Review and compilation of technical documentation
  • Examination of clinical evidence
  • Preparation and submission of conformity assessment, manufacturer’s evidence and product-related inclusion applications
  • Evaluation of clinical evidence, labelling and advertising
  • Clinical trial/stability trial protocol evaluation
  • Liaison with TGA, Medsafe
  • Review of technical documentation
  • Ingredient screening
  • Labelling and advertising assessment
  • Claim examination
  • Preparation of relevant submissions to TGA or AICIS
  • Screening of formulations
  • Review of efficacy data
  • Labelling and advertising assessment
  • Preparation and submission of product-related applications to TGA
  • Liaison with TGA
  • Screening
  • Review of technical documentation
  • Labelling and advertising assessment
  • Preparation and submission of applications to relevant regulator
  • Ingredient screening
  • Labelling and advertising assessment
  • Claim examination
  • Ingredient-related submissions including for assessment certificates to AICIS
  • Liaison with AICIS
  • Formulation screening
  • Labelling and advertising assessment
  • Preparation of high-quality submissions and proposals to change the Australia New Zealand Food Standards Code including for novel foods, health claims
  • Liaison with FSANZ
  • Preparation of high-quality submissions for new and changed registered products, active constituents and permits
  • Preparation and review of labels
  • Liaison with APVMA
  • Project management
  • Provision of regulatory and technical advice
  • Guidance on development and commercialisation issues
  • Assistance with regulatory compliance
  • Recalls management and liaison with TGA, Medsafe
  • Training on regulatory matters
  • Regulatory due diligence and strategising
  • Data gap analysis and development of approaches to address deficiencies in dossiers and documents
  • Clinical trial review, notifications and approval submissions
  • Literature searching, evaluation and reporting
  • Scientific and regulatory writing
  • Regulatory agency interaction support
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