- 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