Regulatory and Manufacturing

Bio Innovation SA is currently building up a regulatory affairs group to assist companies and research organisations to undertake work in the areas of preclinical, clinical trials and manufacturing, as well as the equivalent areas in agricultural biotechnology.

A key objective in this area is to advise South Australian bioscience companies and research organisations on all aspects of regulatory affairs, and to provide appropriate linkages and access to the TGA, FDA, NATA and the Office of the Gene Technology Regulator (OTGR). The type of assistance that will be provided includes:

• Pre-clinical development or equivalent in agbio fields
• Reviewing and providing guidance for labelling and advertising of products
• Providing guidance on regulatory compliance
• Assisting with the preparation and content of regulatory submissions
• Reviewing company practices and providing advice on changes to systems
• Assisting with GMP, GLP and GCP requirements

For further information, please contact Jo-Anne Taylor, Project Manager – Regulatory Affairs at jo-anne.taylor@bioinnovationsa.com.au or phone +61 8 8217 6400.