- Developing tailored regulatory strategies
- Reviewing international dossiers for local compliance
- Conducting gap analysis and strategic planning
- Providing Pre-Application Assistance (PAA) for submissions and meetings with regulatory authorities
- Coordinating with Contract Research Organisations (CROs) and supervising studies
- Engaging with regulatory experts in informal settings
- Assessing nutritional and digestive products for potential compliance with exemption legislation
- Developing comprehensive registration dossiers
- Crafting technical and scientific arguments
- Preparing documentation for electronic submissions
- Submitting applications and coordinating with regulators
- Responding to inquiries, clarifications, and regulatory notices
- Offering strategic guidance throughout the application process
- Guiding, developing, and submitting variation applications
- Reviewing commercial product labels and artwork for regulatory compliance
- Coordinating the development of product Safety Data Sheets (SDS)
- Developing Globally Harmonised System (GHS) labelling requirements
- Acting as a Nominated Agent (NA) for international registrants and Australian companies, including Authorised Agent services
- Assisting with the management of annual renewal fees, levies, and international Good Manufacturing Practice (GMP) fees
- Facilitating import permits through the Department of Agriculture, Fisheries and Forestry (DAFF)
- Securing Consent to Import (APVMA)
- Managing Class Determinations (ACVM)
- Connecting with Contract Research Organisations (CROs)
- Coordinating with Contract Manufacturing Organisations (CMOs)
- Identifying distribution partners
- Collaborating with formulation chemists
- Supporting GMP auditors
