Brett Mooney Email and Phone Number

An experienced pharmaceutical leader with 30 years experience in pharmaceutical product development specialising in oral solid dosage formulation of immediate and modified release tablets and capsules, oral contraceptives, soft gelatin capsules, medical devices, analytical development and validation for active pharmaceutical ingredients and finished dosage forms; API DMF critique and selection; strategic planning for product development from API to commercial launch; pharmacokinetics; patents; Regulatory Affairs CMC covering registrations into Europe, Canada, Australia, USA including Paragraph IV FTF filings, Japan, South America and SE Asia countries.Management Competencies:Leadership/Team building;Project Management;Financial Management;Business Development;Executive Team contribution.Technical Competencies:Formulation of high potency drug products, modified release and immediate release tablets/capsules, soft gelatin capsules;API DMFs and selection;Analytical development and validation;Process Validation;Regulatory Affairs CMC of new products and product compliance;Bioequivalence/Bioavailability study design, protocol review and study coordination;