Biopharma Regulatory Consulting

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.