BioPharma Regulatory Consulting
Pharmaceuticals - Brisbane, Queensland, Australia
BioPharma Regulatory Consulting Employees
BioPharma Regulatory Consulting Details
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 guidanceBPR also provides expert consulting in regulatory affairs within the major regulatory jurisdictions for all therapeutic medicinal products.
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