We understand Therapeutics Regulation in Australia and New Zealand.
Archer Emery and Associates are a team of highly qualified, highly trained professionals. But our career experience goes beyond the therapeutics industry.
We bring many years’ experience working within the Therapeutic Goods Administration (TGA), at senior management level, to every project. It’s this rare knowledge that gives us an edge.
Archer Emery and Associates and be YOUR TGA Consultants. Contact us now for more information or to get your project started!
Julie Emery has worked in the pharmaceutical industry for over 25 years.
She has 10 years Therapeutic Goods Administration (TGA) experience as Manager of the Client Services and Secretariat Unit in OTC Medicines and Manager of the Australian Register of Therapeutic Goods, as well as 15 years industry experience.
Julie has assisted a wide range of clients since founding AEA in 2006. She provides expert advice on the regulation of medicines, medical devices including IVDs and disinfectants, cosmetics and foods. She is also an expert trainer who has run many workshops for Australian and overseas personnel.
Julie is qualified in Microbiology, Law and Management (including Technology Management) and specialises in TGA systems, product applications, legislation, labelling and staff training.
Alan Duff has been with AEA from the start, over 16 years ago. Prior to AEA, Alan’s experience covers 11 years in the industry and 21 years in the Therapeutic Goods Administration (TGA) – most recently as Head of Post-Market Review of OTC Medicines.
As a Senior Good Manufacturing Practice Auditor in the TGA, he audited many production plants in Australia and around the world and worked closely with regulatory agencies in numerous South East Asian countries as well as US FDA. He has run training in Australia and Overseas.
Alan is qualified in Chemistry and Business Administration, and specialises in GMP auditing, GMP training and technical advice on quality of medicines. He is our globally acknowledged GMP expert.
Donné Field has worked in the pharmaceutical field for over 25 years. She has almost 10 years of experience in hospital pharmacy as a pharmacist and Assistant Pharmacy Manager in a large private hospital network in South Africa, as well as other experience in community and wholesale pharmacy.
Donné moved to regulatory work in 2011 as Regulatory Support Pharmacist at a multi-national pharmaceutical manufacturer. She gained industry experience with OTC, prescription and injectable products for local and international regions.
After moving to Australia, she began her journey as Regulatory Affairs Consultant with Archer Emery & Associates in 2015. She has assisted clients with a range of regulatory work including OTC and complementary medicines, medical devices, cosmetics and foods. She has also assisted Julie with training workshops for complementary medicines and medical devices.
Donné completed her Pharmacy degree in South Africa. Her regulatory work is focused on TGA product applications or variations for medical devices, OTC and complementary medicines as well as labelling and cosmetic enquires.
Rose Meinzer has worked in the Pharmaceutical industry for over 10 years, specialising in compliance of Quality documentation and Quality systems.
Rose spent 8 years in the Quality Department at a multinational pharma company in South Africa, and 2 years as Quality Manager for a local company. As Quality Manager she was responsible for implementing the Quality Management System and obtaining the GMP manufacturing license for the company as well as registering 5 new antimicrobial OTC products on the ARTG.
Rose has assisted a wide range of clients since joining AEA in early 2020 and provides expert advice on the regulation of medical devices including IVDs, disinfectants, OTC medicines, cosmetics and foods.
Rose has a degree in Microbiology and a Master’s degree in Biochemistry and specialises in product applications, antimicrobials and labelling.
Morgan has been working at AEA as an Administrative Assistant since late 2020, assisting with client queries, accounts and a variety of other tasks. Prior to working at Archer Emery she worked at a litigation & employment law firm as a legal secretary in New Zealand and in various client-facing administrative roles in the hospitality industry and retail sector.
Morgan is a friendly and helpful person who is client focussed, organised and works well under pressure. Morgan holds various certificates in administration related topics and will be happy to assist you quickly and efficiently.