OUR SERVICES
Admirus Consulting offers a range of Medical, Regulatory and Compliance services that support organisations in the biotechnology and healthcare industries.
Our consultants have extensive global experience in Medical Affairs, Regulatory Affairs, Due Diligence and Healthcare Compliance which positions us as the ideal partner for your business.
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MEDICAL AFFAIRS
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Prelaunch market preparations, strategy and launches
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Clinical/scientific and strategic consulting
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Advisory Boards
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Key experts mapping
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Medical training
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Medical education programmes
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Medical input into market access value dossiers and regulatory submissions
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Medical and scientific communications
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Publications and scientific resources, medical materials
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Promotional material review
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Medical Information
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And more
2
REGULATORY AFFAIRS
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Global, regional and local strategic regulatory advice and support
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Creation of development plans and registration strategies
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Evaluation of regulatory requirements to bring EU/US approved products to Asia-Pacific markets
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Regulatory gap analyses and risk assessments
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Early pre-clinical and clinical development advice
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Small molecule and biotechnology
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Regionalisation/localisation of Global Clinical Development Plans
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Business Development pre-Due-Diligence assessment to identify red-flags
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Intellectual Property and regulatory impact assessment
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Health Authority Meeting preparation and attendance
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Drafting and review of key regulatory submission documentation, HAQs, etc
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Competitor product review and data assessment for labelling advantage
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Labelling negotiation/advice
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Promotional material review
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And more
3
DUE DILIGENCE
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Business Development pre-Due-Diligence assessment to identify any red flags or regulatory risks
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Key insights for Investment Fund managers: assessments of drug development, key regulatory success factors, regulatory risk assessments. Red Flag identification etc
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Regulatory gap analyses, risk assessment
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Intellectual Property and regulatory impact assessment
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Regulatory input to Business Case Assessments
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Maximisation of commercial opportunity through creative regulatory strategies
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Significant expertise in evaluating regulatory requirements to bring EU/US approved product to Asia-Pacific markets
4
HEALTHCARE COMPLIANCE
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General advice for all Healthcare Compliance matters
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Promotional material review
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Labelling advice
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Medicines Australia Code of Conduct reporting support
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Medicines Australia Code of Conduct case investigation and support
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Corporate compliance internal case investigations and advice
