BioPharma Regulatory Consulting provides Australian-focused regulatory affairs consulting. Services focus on the requirements for clinical trials and marketed products for therapies that are Genetically Modified Organisms (GMOs) and include: - Expert advice on the regulation of GMOs therapies in Australia - Classification, writing and review of GMO licence applications and exemption documentation - Guidance throughout the Institutional Biosafety Committee (IBC) and Office of the Gene Technology Regulator (OGTR) evaluation processes - Assistance with implementation of GMO licence conditions including staff training - OGTR accreditation guidance BPR also provides expert consulting in regulatory affairs within the major regulatory jurisdictions for all therapeutic medicinal products.