Who We Are

Dr Rosalie Cull is a power networker with multiple business interests in Australia/New Zealand and internationally. She is Managing Director of TudorRose Consulting Pty Ltd and a former Non-Executive Director of ARCS Ltd, as well as being a foundation member of the New Zealand Biotechnology Association.

A protein chemist by training, Dr Cull has a PhD in Biochemistry from La Trobe University, Melbourne and is also a graduate member of the Australian Institute of Company Directors.

Dr Cull has been involved in the successful development and commercialization of prescription medicines, novel delivery systems and devices for over 30 years and has worked for a host of well-known and innovative, Australian, US, European, and NZ companies including: Acrux DDS Pty Ltd, Kendle Australia, CSL, Faulding Pharmaceuticals Biotech Australia, Massey University (New Zealand) and Alapharm (New Zealand).

Deb Cooper has extensive experience in consulting roles, both in Australia and internationally. She has spent a large proportion of her career in multinational innovator companies in Australia and the UK and in senior project management roles in Australian and international consultancies.

Deb also spent more than 5 years leading the regulatory affairs, medical devices and pharmacovigilance divisions within ARCS Australia Ltd, the Australian industry association for professionals in the therapeutic goods development industry.

Deb has proven project management skills; a very broad local and international industry network; and extensive experience working in close collaboration with government; in combination with an appreciation of commercial drivers.

Deb holds a BSc(Hons) in Industrial Chemistry and a Graduate Diploma in Drug Development, both from the University of New South Wales. She also has a Certificate IV in Training and Assessment (The Gordon) and a Diploma of Project Management with the Australian Institute of Management.

Madeleine holds a BA/BSc from the University of Auckland, and has spent her career leading projects in regulatory affairs and medical writing in the pharmaceutical industry.

With extensive experience in the regulatory environments of Australia and New Zealand, Madeleine has worked on a a wide range of medicines and medical devices across varying therapeutic areas. Working with partners from around the world, Madeleine has collaborated on projects at all stages of a product’s lifecycle – from product development, clinical trials and dossier compilation, through to regulatory approval, commercialisation and post-marketing maintenance.

Having also led projects for the US, Canada, EU and Asia, Madeleine is adept at utilising knowledge of the global regulatory context to inform and optimise commercial strategies for Australia and New Zealand.

Kelley has over 10 years experience working for a large biopharmaceutical company, gaining broad regulatory experience in prescription medicines in both the Australian and New Zealand markets.

Her experience spans the approval of new chemical entities across a range of therapeutic areas. She has also held a senior role in Medical Affairs and has experience in food legislation for a number of different countries.

Kelley is knowledgeable on a wide range of submission types, both pre-and post-marketing, and has a pragmatic approach to creating regulatory solutions. She is a good communicator and enjoys working in global team environments.

Hunchul has over 9 years of regulatory affairs experience with 10 years in prior roles across R&D, quality control, and quality management systems in pharmaceutical and medical device industries.

His pharmaceutical experience includes Category 1 applications, Category 3 applications, development of Risk Management Plans, responses to agency requests for information and management of GMP clearance applications.

His device experience includes review and/or development of product technical file (CER, RMF, ER/EP, IFU/labels) across Class I-III devices.

With sound technical knowledge, attention to detail, and a network of highly qualified regulatory professionals, Hunchul takes a holistic and pragmatic approach to market authorisation of challenging therapeutic products. He uses his extensive R&D, quality, and regulatory management experience to tackle projects with agility and detail, resulting in effective strategies and, often, simple solutions to complex problems.

Carl has a long history of working in manufacturing environments, including News Corp Australia businesses. He is well versed in managing timelines and external vendors, having previously held a similar role in the health space, for TudorRose Consulting Pty Ltd.

Emma brings a wealth of experience in customer service, logistics, legal regulations and procedures. She has previously worked in the wholesale energy sector and in a legal firm.