Novotech initiated the first national, privately owned, commercial Institutional Biosafety Committee (IBC) in Australia, successfully accredited by the Australian Office of the Gene Technology Regulator (OGTR).
Having access to an IBC is a prerequisite for an organisation to obtain and maintain accreditation for the conduct of studies using investigational products that are genetically modified organisms (GMOs) in Australia. All necessary license and notification applications require review from an IBC before successful applications can be submitted to the OGTR. Novotech Novotech Drug Development Consulting has extensive expertise in providing Cell therapies services and GMO services for biotechnology companies.
We are an accredited organisation with the OGTR
The IBC provides GMO classification advice and performs the review and submission of GMO licence applications and notifications to the Office of the Gene Technology Regulator. The GMO classification types in Australia include ‘Exempt Dealings’ (GMO products or ‘dealings’ not requiring a GMO licence), Dealings Not Involving Intentional Release (DNIR), Dealings Involving Intentional Release (DIR) licensable GMOs, or Notifiable Low-Risk Dealings (NRLDs).
As a full-service CRO, Novotech can act as both the Applicant for the GMO licence and the Sponsor of the clinical trial. This dual capability allows for the streamlining of Australian sponsorship for clinical trials using GMOs as Novotech can be responsible for all monitoring aspects of the study. However, if a company has a legal Australian entity, they can choose to be the applicant and hold the DNIR or DIR license ensuring the conditions of the license are upheld throughout the trial.
Novotech will provide ongoing support throughout the evaluation phase of the DNIR or DIR with the Office of the Gene Technology Regulator and will respond to questions raised by the Office of the Gene Technology Regulator in writing following consultation with our client.