Comprehensive consulting services for GMO therapies in Australia

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• Expert advice on the regulation of GMOs therapies in Australia for clinical trials and marketing
  Therapies that are genetically modified organisms (GMOs) such as genetically modified viral vector products, with few exceptions,
  require review by an Institutional Biosafety Committee and the Office of the Gene Technology Regulator (OGTR) 

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• Access to BPR's expert independent Institutional Biosafety Committee​
  Click on the Institutional Biosafety Committee menu to find out more 

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• Classification, writing and review of GMO licence applications and exemption documentation providing end-to-end guidance for GMO therapies​

        With input from the Institutional Biosafety Committee, BPR can perform an assessment, based on the therapy type and intended use, to determine which OGTR licence is applicable (if any).

        BPR can write the application documentation, perform the IBC review, assist during OGTR review and help implement the licence conditions for a clinical trial

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• Staff training services​
  BPR can generate clinical trial staff training materials and clinical trial documentation specific for GMO therapies in clinical trials.
  BPR can also train clinical trial staff on the conditions of the GMO licence

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• GMO-specific SOP writing for clinical trials

       BPR can advise and write the GMO-specific SOPs describing the requirements and conduct for GMO clinical trials in Australia

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• OGTR accreditation guidance​
  If performing clinical trials with GMOs, the licence holder should be accredited with the OGTR. Accreditation requires access to an Institutional Biosafety Committee.
  BPR can provide guidance for the application process and access to the BPR IBC

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• New Zealand​
  Planning to import a GMO therapy to New Zealand for use in clinical trials? Talk to us about the process and how we can help

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BioPharma Regulatory Consulting Pty Ltd
ABN 78 654 734 915