Tara Creaven-Capasso, RAC, RQAP-GLP
Areas of Expertise
◎ Product development
◎ Product registration/approvals/market clearance
◎ Regulatory strategy development
◎ Regulatory submission preparation
◎ Quality system establishment and maintenance
◎ GXP compliance
◎ Regulatory body inspections
◎ Regulatory agency meetings
◎ Evaluation and risk assessment of products
◎ Non-clinical and clinical research protocol design and development
◎ Evaluation of field complaints and medical device reporting
◎ Due Diligence
◎ Commercialisation strategy development
With over 24 years of experience servicing the biomedical, pharmaceutical life science and veterinary healthcare sectors in the US, Europe, Japan, China, Australia and New Zealand.
Tara founded Caduceus Medical Development, Ltd. In the United States in 2007 and most recently expanded to Australasia opened an office in New Zealand in 2014.
Tara provides support both in early-stage and mature life science organizations and is responsible for commercial activities around due diligence for prospective investors as well as corporate boards. Additionally, Tara helps company’s resolve issues around development and commercialization challenges and therefore creating new opportunities for the business. Additionally, she has been successful in strategic and business planning, product development and commercialization as well as day-to- day operations.
Tara actively participates in industry groups and meetings such as the Regulatory Affairs Professionals Society (RAPS), Society of Quality Assurance (SQA), the Society of Public Responsibility in Medicine and Research (PRIM&R) and is also a member of Life Science New Zealand. She is also an Invited speaker at national and international venues as well as an invited educator to industry and academic institutions on topics relating to regulatory affairs, regulatory sciences, quality and compliance with respect to US FDA and international regulations.