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regulatory services

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Regulatory strategy, TGA product registration, FDA compliance, 510k/PMA submissions, MDD & IVDD technical files/design dossiers, medical device reporting (MDR), post market surveillance

commercial services

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ANZ sponsorship for international companies, market assessment, product launch strategies & evaluations, selection & ongoing management of distributors, competitor analysis, tender submissions

clinical

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Clinical strategy & trial management, protocol development, clinical marketing, post-market feedback & data analysis, identifying key opinion leaders (KOLs), preparation of abstracts & manuscripts

quality services

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Quality Management Systems (QMS) consulting & training, ISO9001/13485 & QSR/GMP gap analysis, SOP & policy development, internal & supplier audits