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Category Archives: Regulatory Services

Relating to Regulatory Services of Life Sciences Industry

Stressed? Well your products should be!

Treating your drug substance or drug product with an acid, a base, an oxidising substance, heat or exposing it to direct light might sound extreme, but that is exactly what the TGA want to see in your registration dossier. Assay … Continue reading

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Medicine labels: TGO 91 and TGO 92. What’s the impact?

Following years of consultation and review the TGA has issued two new labelling orders to replace the current Therapeutic Good Order No. 69 for specific medicine labelling requirements: Therapeutic Goods Order No. 91 – Standard for labels of prescription and … Continue reading

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Commercial Eyes Recruiting: Regulatory Services Manager

Commercial Eyes has a great opportunity for a Regulatory Services ManagerReporting to the Director, Regulatory Services, the Manager is responsible for the day to day operational management of the regulatory team and the assigned project portfolio within the Regulatory Services … Continue reading

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Warning: This medical device literature review may contain traces of LBS

With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation reports (CERs). Once final, this guidance will be used in … Continue reading

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Ready? Get Set…Go! Planning the most appropriate strategy for your product to enter the Australian market

As we weave our way through life, we plan…plan our career, plan our finances, plan a holiday and most of us would have at least once in our lifetime planned a party. The key to a successful plan is finding … Continue reading

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Are you eCTD ready?

eCTD in Australia Following the successful eCTD pilot programme in 2014/2015, the TGA has published the final Australian eCTD specification (version 3.0) which is now mandatory for all dossiers submitted in eCTD format after 1 January 2016. This is an … Continue reading

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Is our product a medicine, a device, a cosmetic, an OTG or a food… and what could it be?

An increasing number of traditionally pharma/device companies are crossing boundaries to offer their patients a product portfolio spanning several product categories. Examples include medical devices that support delivery and tracking of patient medication as well as cosmetic and sunscreen line … Continue reading

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Dr Greg Pearce – Time to support biosimilars

Dr Greg Pearce, from our Regulatory Services team, has written a follow-up article for Pharma in Focus on biosimilars. Dr Pearce’s first article focussed on the challenges biosimilars pose for the Australian medicines industry. This second article looks at the … Continue reading

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Using an overseas reference product in your bioequivalence studies

It is the TGA’s preference that bioequivalence (BE) studies to support generic medicines are performed using the Australian (AU) innovator product as the reference; however, within certain TGA conditions, it is possible to use an overseas reference/innovator product in your … Continue reading

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Commercial Eyes recruiting: Regulatory Consultant

Commercial Eyes has a unique opportunity for an experienced professional to join our Regulatory Services team In this role, you will be providing Regulatory Affairs and Quality consulting services to the clients of Commercial Eyes. This position may be based … Continue reading

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