Ready? Get Set…Go! Planning the most appropriate strategy for your product to enter the Australian market
The key to a successful plan is finding the right resources to help us make informed decisions that suit our...
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Medicine labels: TGO 91 and TGO 92. What’s the impact?
The creation of separate orders for prescription and non-prescription medicines was implemented to reflect how the products are used and ensure adequate information is available for the safe use of...
Are you eCTD ready?
While the eCTD format is not currently mandatory in Australia, it is only a matter of time before the TGA joins other global regulators in mandating...
Stressed? Well your products should be!
Stress-testing is an important validation consideration and should be conducted very early in the development or implementation of new test methods rather than leaving it until regulatory authorities raise questions...
Keys to off-label communications
The TGA and the Medicines Australia Code of Conduct are very clear on the appropriateness and dissemination of off-label information to...
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....
Using an overseas reference product in your bioequivalence studies
In order to consider whether this process is possible, the TGA have a list of exclusion criteria regarding the use this...
Release for supply – What every sponsor should know
Every batch of medicine sold or supplied in Australia is required to have undergone a “release for supply”...
5 reasons to call in the experts: Establishing a pharma business in Australia
Commercial Eyes has assisted a number of companies to establish a pharma business in Australia, so what are 5 reasons to call in the...
Medical Information by instant message
1800 numbers and written responses such as letters and emails are a well-established part of all Medical Information services. However consumers and healthcare professionals are increasingly tech-savvy....
A PV database to meet your needs… and your budget
Just as medicines and medical devices are held to stringent quality controls, so too is the software used to support the safety and efficacy of those same medicines and medical...
Innovation in Healthcare: Aligning clinical development and commercial strategies
From penicillin to the human genome, innovation can generate great leaps in...