Worried about TGA Complementary Medicines Compliance?
PharmOut is the most experienced Australian regulatory and GMP consultancy with a proven track record in offering practical advice and guidance which has enabled local and international manufacturers and sponsors to enter the Australian dietary supplements (also known as complementary medicines) market. This can include vitamin, mineral, herbal, aromatherapy and homoeopathic products.
The TGA actually classifies Dietary Supplements in the ‘lowest risk’ category for Medicines (sun screen also falls into the same bracket) and have published a series of helpful articles on their website to clarify the issue. Despite this, the ‘Medicines’ classification can still be confusing to manufacturers when having to consider which of the regulations apply and how to be compliant.
In instances like these, where the path to compliance is confusing, we are in the requirements and understand how to navigate through the regulatory terrain.
We offer continuous improvement consulting services where we can utilise a Lean Manufacturing and Six Sigma mindset to examine your complementary medicines facility, equipment and processes.
GMP compliance can be tricky – which regulations, which interpretation, where to start? We can help you develop a GMP compliance roadmap and get you going in the right direction.
If you have a regulatory audit coming up, it’s wise to have one of our consultants perform a pre-audit in order to identify any problems you may have in advance (and so the auditor doesn’t catch you out on the day!).
If you’ve got a project looming in the distance and you have no idea where to begin, we can offer project management services to help you get production up and running and complying with the relevant regulations.
PharmOut offers a wide variety of training courses to suit your Complementary Medicine needs. These courses can be delivered on-site or online, as well as in public courses in a city near you.
If you’re resource poor we can help you finding temporary or permanent staff with specific technical skills and experience to support your manufacturing and site activities.