Developing regulatory strategy

Reviewing dossiers produced for international jurisdictions to ensure local compliance

Gap analysis and planning

Pre-application Assistance Application (PAA) submissions and meetings with APVMA

Liaising with Contract Research Organisations (CROs), including study supervision

Liaising with regulator experts in less formal contexts

Assessing nutritional and digestive products for potential compliance with exemption legislation

Developing registration dossiers

Writing technical scientific arguments

Creating documentation for electronic submissions

Submitting applications and liaising with regulators

Responding to questions, clarifications and regulatory notices

Providing strategic guidance throughout the application process

Variation application guidance, development and submissions

Reviewing commercial product label text and artwork for regulatory compliance

Commissioning product Safety Data Sheet (SDS) development

Developing Globally Harmonised System (GHS) labelling requirements

Acting in a Nominated Agent (NA) function for international registrants (who must appoint an Australian NA to act on their behalf) and Australian companies (who can appoint an Authorised Agent if they wish)

Assistance with the management of annual renewal fees and levies, including international Good Manufacturing Practice (GMP) fees

Import permits (Department of Agriculture, Fisheries and Forestry (DAFF))

Consent to import (APVMA)

Class Determinations (ACVM)

Contract Research Organisations (CROs)

Contract Manufacturing Organisations (CMOs)

Distributors

Formulation chemists

GMP auditors