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 TudorRose Consulting is now part of Adjutor Healthcare.   Same team.   More Expert Services.    Meet Adjutor

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A global provider of development and commercialisation services to the pharmaceutical, biotechnology and medical device industries.

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Commercialization

Personalised Medical Devices, along with four new sub-categories, now replace the former Custom-made Medical Devices regulation.

Custom-made Medical Devices in Australia: Now it’s Personal(ised)

March 5, 2021 //  by Adjutor Healthcare

Recent changes in TGA Medical Device Regulations In December 2020, TGA released a new Personalised Medical Device Guideline along with a suite of new names and definitions that have shaken up the niche and specialised Custom-made Medical Devices sector. The new guidance reflects amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, meaning that compliance …

Custom-made Medical Devices in Australia: Now it’s Personal(ised)Read More

Category: Regulatory AffairsTag: Adjutor, ARTG, Commercialization, Medical Devices, Quality, Regulatory Consultants, TGA, Therapeutic Goods

Artificial Intelligence Regulation. AI poses ethical, legal, and socio-economic dilemmas such as data sensitivity, privacy, and cyber security.

Artificial Intelligence Regulation

January 28, 2021 //  by Adjutor Healthcare

Is Artificial Intelligence Becoming Too Smart for Regulators? AI is Everywhere and it isn’t that New! The term ‘artificial intelligence’ (AI) was first coined in the 1950s. Since then, this disruptive idea has come a long way from concept to reality. From enhancing photos for your social media page to detecting diseases from medical images, …

Artificial Intelligence RegulationRead More

Category: Adjutor HealthcareTag: Adjutor, AI, Artificial Intelligence, Commercialization, Machine Learning, Medical Devices, Quality, Regulatory Affairs, TGA, Therapeutic Goods

Image depicts the Australian government 2020 budget cash splash on high tech and science recovery.

Australian Government Cash Splash on High Tech Recovery

October 15, 2020 //  by Adjutor Healthcare

Australian science and technology sectors are talking about a ‘research revival’ as the Federal Government splashes the cash in the 2020 Budget. 2020 Budget Cash Splash Thanks to COVID-19, early October saw the first Australian federal budget delivered in a recession in 30 years. The Treasurer said personal income tax cuts, infrastructure spending, and business …

Australian Government Cash Splash on High Tech RecoveryRead More

Category: Adjutor HealthcareTag: Biotech, Clinical Trials, Commercialization, Development, Federal Budget, Manufacturing, Medical Devices, Medicines, Medtech, PBS, Pharma, Therapeutic Goods

TGA's new Product Information (PI) Form: If you need support to meet the 31 December 2020 deadline, we’re here to help.

The Pointy End of the PI Reformatting Transition Period

March 20, 2020 //  by Adjutor Healthcare

By now, we should all be very familiar with the new Form for providing Product Information (PI) for Australia. Each time you make a change to a PI, be it safety-related or otherwise, you’re required to provide the updated PI to TGA in the new format. The looming deadline for marketed product PIs to be …

The Pointy End of the PI Reformatting Transition PeriodRead More

Category: Adjutor HealthcareTag: Australia, Commercialization, Medicines, Product Information, Regulatory Affairs, TGA

Therapeutic Product Commercialization - We may have a global market but do we really consider options outside of USA and EU enough when developing our strategy?

Therapeutic Product Commercialization

March 11, 2020 //  by Adjutor Healthcare

We may have a global market but do we really consider options outside of USA and EU when developing our Therapeutic Product Commercialization strategy? The USA, EU/UK are large markets with clear regulatory requirements, so they are often first targets for therapeutic product commercialization, either for medicines or medical devices.  A New Perspective But what …

Therapeutic Product CommercializationRead More

Category: Adjutor HealthcareTag: Commercialization, Global Markets, Medical Devices, Medicines, Strategy, Therapeutic Goods

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Adjutor Healthcare Pty Ltd is part of a worldwide network that spans 90 countries.

We provide seamless services across development and commercialization of your products internationally.

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Adjutor Healthcare Pty Ltd

  +61 418 314 763

  rosalie.cull@adjutor.com.au

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