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Adriaus Consulting offers a complete package of specialist expertise in Global Regulatory Affairs, Strategy and Project Management

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GLOBAL REGULATORY AFFAIRS

We offer specialist skills in Global Regulatory Affairs and provide advice and expertise in regulatory processes of the United States, Europe, Australia, New Zealand and others. We lead, facilitate and prepare all types of global regulatory submissions. We liaise, meet and negotiate with Regulatory Agencies. We communicate and enlist your teams on pathways to success. We monitor international regulatory trends and assess their impact on development projects, programs and products.

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STRATEGY

We develop, market, communicate and execute global regulatory strategies for product development and commercialisation programs. Using our vast and in-depth experience, we develop and execute innovative strategies to solve your problems.

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PROJECT MANAGEMENT

We lead, facilitate and project manage complex regulatory submissions that lead to successful outcomes. We effectively communicate with your global and local stakeholders. We develop and implement systems and processes to increase operational efficiencies. We monitor and correct project progress.

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PRINCIPAL CONSULTANT

Adriana Stefancic is the Principal Consultant and Managing Director of Adriaus Consulting. She will personally provide all consulting services. Adriana has an extensive track record of success with global Regulatory Agencies, including the FDA, TGA, EMA, Medsafe and others. She is vastly experienced in all stages of product development, commercialisation and life-cycle management of medicines.

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