Mrs Zamudio is responsible for; PAH’s GMP accreditations and licensing with APVMA, EMEA, FDA and other relevant Authorities and sign-off on raw materials and components for further manufacture and packaged product for marketing, stability protocols and evaluations for designated raw materials and finished product and on finished product to Australian and overseas markets and, where appropriate, for clinical trial materials.
In conjunction with R&D, Production and Regulatory staff, Mrs Zamudio assists in the development of pre-registration products and their documentation in Australia, Europe, US and elsewhere.