In the therapeutic goods business, success depends on two things; providing a quality product that works, and mastering the regulatory environment you have to work within.
The regulations are complex, and constantly changing, and it can be very difficult for one organisation to provide the level of expertise needed to successfully deal with bodies like the Therapeutic Goods Administration (TGA).
That’s where we can help.
Archer Emery and Associates are specialist consultants on OTC and complementary medicines (drugs), medical devices, cosmetics and foods – and the regulatory requirements that govern their use in Australia and New Zealand.
We have extensive experience in the private sector, and we are the only consultancy team with over 50 years of experience working in senior positions within the TGA.
We know the regulations, the systems and the people well. And we bring this knowledge to every project we work on.
Talk to us! We’re the consultants who can help you achieve the best possible outcomes in all your dealings with the Therapeutic Goods Administration and Medsafe.
Archer Emery and Associates – the Therapeutic Goods Administration (TGA) Experts. To find out how to enhance your regulatory team and maximize your chances of success – whatever the project. Click here to get in touch >>
The type of application you make depends on the type of medicine product you have, depending on the ingredients it contains and/or the indications (therapeutic claims) you wish to make. Some products need to be ‘registered’ and undergo a full evaluation, while others fall within the ‘listed’ classification and can be almost fully self-assessed. Some fall in between. Knowing the difference can save you a lot of time and money.
Regulatory authorities like the Therapeutic Goods Administration (TGA), Medsafe, the various European authorities and the US FDA require manufacturers of medicines to comply with strict standards on Good Manufacturing Practice (GMP).
We can help you identify which devices are ‘medical devices’, which are ‘therapeutic devices’ and which are ‘in-vitro diagnostics’ (IVDs). We know the requirements for each category and we can help you ensure that you have the correct documentation to support approval in Australia.
Effective product labelling is not just about squeezing all the technical and legal requirements onto your pack – although that’s often a huge challenge in itself. Your labels have to give consumers the confidence to choose and use your product correctly.
The boundary between therapeutic goods and cosmetics or foods can be blurry. It might be a word or two, or a minor reformulation that is all that is needed to position your product as a food or a cosmetic rather then a medicine or medical device, or vice versa.We can assess your products and advise on options that will help you achieve your goals in the a way that suits you best.
Therapeutic products are regulated in New Zealand by Medsafe. New Zealand is in the process of updating its legislation and the new rules will come into effect soon. We can help you navigate through both the existing and upcoming New Zealand requirements for therapeutic products.
Our professional Staff Training courses are based on our senior consultants’ years of experience in training TGA staff and staff from other regulatory agencies across the Asia Pacific region. We can give your staff the skills and knowledge required to deal confidently and competently with the TGA and Medsafe, the agencies regulating your business.
At Archer Emery & Associates we provide a range of other services related to therapeutic products.
A sponsor for your medicine or medical device