History
In 2013, after many years in the Pharmaceutical and Medical device Industries, Sonja Cuce establish a boutique consulting business in Melbourne, Australia. The philosophy is to work with companies to facilitate the registration and regulatory compliance of Medicines and Medical Devices specifically with Therapeutic Goods Administration (TGA- Australia) and MEDSAFE (New Zealand).
Specialising in tailored regulatory strategies, advice, training, mentoring and support to streamline the registration of Therapeutic Goods for innovator and established companies.
Get in touch with Sonja to set up a consultation, or use the contact form at the bottom of this page to enquire whether I can help you.
Get in touch
We at Belsyme know that finding the Regulatory support to help your business choice not to be taken lightly. That’s why we offer free initial assessment to walk you through your needs, the scope of the project, and how I can help you.
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Principal Regulatory Consultant
Sonja Cuce
Sonja Cuce, is the Principal Regulatory Consultant and Regulatory expert at Belsyme Pty Ltd. She has over nearly 30 years’ experience in Pharmaceutical and Medical Devices industries specialising in .
This includes Regulatory Affairs as well as manufacturing, planning, quality and management. of Australian and Regulatory requirements for. She has experience in strategic regulatory advice and services through all stages of the product life cycle in a wide range of therapeutic areas from Pharmaceutical and Medical Device provides.
She has worked in two global organizations CSL and Hospira (formally Mayne Pharma), where ANZ Regulatory Affairs Manager. She has specific Regulatory Affairs knowledge in the Medical Devices, biologicals, prescription medicines, OTC and sterile injectable generic and proprietary domains. Her pharmaceutical expertise spans.
Sonja is currently a member of the TGA Prescription Medicine Industry Working Group (IWG), where she has been able to directly influence the regulation of Prescription Medicine in Australia. She is the convenor of ARCS Medical Devices Interest Group and has presented and chaired a number of ARCS conference sessions as well as at PDA Australia events.