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Category Archives: Regulatory Services

Relating to Regulatory Services of Life Sciences Industry

Commercial Eyes Recruiting: Consultant, Regulatory, Quality & Compliance

  The Opportunity The Consultant works within the Regulatory, Quality & Compliance team to deliver a range of regulatory applications for Australia and New Zealand.  The Consultant manages client projects, working closely with other members of the team, to deliver … Continue reading

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Commercial Eyes recruiting: Associate Consultant, Regulatory, Quality & Compliance

    The Opportunity The Associate Consultant works within the Regulatory, Quality & Compliance team to contribute to the regulatory, quality and compliance consulting practice. The Associate Consultant is responsible for the preparation and submission of a range of regulatory … Continue reading

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New TGA framework to redefine personalised medical devices

This post will cover the recent changes brought to regulation of personalised medical devices, under a new TGA framework. Continue reading

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Commercial Eyes Recruiting: Senior Manager, Regulatory, Quality & Compliance

The Company Commercial Eyes is Australia’s foremost Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & NZ.  What we do – and the consistent excellence with … Continue reading

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Coronavirus (COVID-19): Information on medicines and medical devices supply in Australia

The Therapeutic Goods Administration (TGA) has consolidated all the COVID‑19 information on their website to assist manufacturers and suppliers with accessing the latest information about the special regulatory requirements for the supply of medicines and devices (including exemptions) in Australia … Continue reading

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Improved Consumer Medicine Information template

The TGA have now released implementation dates for the updated Consumer Medicine Information (CMI) template that was developed throughout 2019 to reduce complexity and improve readability. Newly registered medicines must use the new template from 1 January 2021, while previously … Continue reading

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Hand sanitiser – What do you need to know to supply in Australia?

The COVID-19 pandemic has seen the TGA rapidly changing the regulatory landscape for in-demand products that can help reduce the spread of the virus. Given all the changes taking place, it can be difficult to ascertain exactly how product categories … Continue reading

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Brexit – What’s the impact on medicines and medical devices supplied in Australia?

  The long-awaited Brexit is underway with the UK exiting the EU on 31 January 2020 A transition period is now in effect until the end of 2020 with the possibility for extension. Its status quo for Australia during the transition … Continue reading

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TGO 91 and TGO 92 – are your labels ready?

Following the 4-year transition period, the medicine labelling Therapeutic Goods Orders (TGOs), TGO 91 for prescription medicines and TGO 92 for non-prescription medicines, will become mandatory on 1 September 2020. Medicines that are released for supply on or after 1 September … Continue reading

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Commercial Eyes appoints Simon Higgins to head up new Commercialisation Services division

Commercial Eyes Pty. Ltd., one of Australia’s most successful health technology commercialisation companies, is pleased to announce the appointment of Simon Higgins to head up it’s new Commercialisation Services division. Simon joins Commercial Eyes with over 20 years’ experience in … Continue reading

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