We are conversant with local and overseas regulations applicable to manufacture of human and animal medicines, medical devices, complementary and alternative medicines and can provide the following services in this regard:
Regulatory Affairs
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Regulatory review and advice regarding classification
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Registration management and planning
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Preparation of submissions for clinical, prescription, OTC medicines and medical devices.
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Sponsor representation
Quality systems development gap analysis and implementation
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Expertise and interpretation of local and international GMPs for medicines, APIs, blood/biologics and devices including Medsafe, TGA, ACVM, APVMA, FDA, EU, China SE Asia and other international jurisdictions.
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Quality risk management strategy and implementation
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Quality system documentation effectiveness organisation and design
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Quality assurance management and training
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Incident investigation, CAPA and operational quality management
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Supplier and contract manufacture assessment and management
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Test method development, trend monitoring and quality review
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Pre and post audit support
Qualification and Validation
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Validation strategy, planning and management
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Risk and Impact assessment
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Leveraging validation activities from procurement and operations
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Process analytics, optimisation, performance qualification, cleaning, decontamination and process validation
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Specification and validation of process automation and monitoring
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Validation of aseptic processing and sterilisation processes.
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Compliance for computer systems, electronic records and signatures
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Analytical/microbiological methods and equipment.
Engineering Support
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Management of integration of GMP requirements into construction and procurement projects.
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Quality systems management for capital projects and contractors
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Design and management of specialist systems such as HVAC, clean rooms; critical processes and utilities and GMP impacted computerised systems.
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Decontamination, cleaning and sterilisation systems