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Regulatory, compliance; validation and engineering support for medicinal products

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
  • Regulatory review and advice regarding classification

  • Registration management and planning

  • Preparation of submissions for clinical, prescription, OTC medicines and medical devices.

  • Sponsor representation

Quality systems development gap analysis and implementation
  • 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.

  • Quality risk management strategy and implementation

  • Quality system documentation effectiveness organisation and design

  • Quality assurance management and training

  • Incident investigation, CAPA and operational quality management

  • Supplier and contract manufacture assessment and management

  • Test method development, trend monitoring and quality review

  • Pre and post audit support

Qualification and Validation
  • Validation strategy, planning and management

  • Risk and Impact assessment

  • Leveraging validation activities from procurement and operations

  • Process analytics, optimisation, performance qualification, cleaning, decontamination and process validation

  • Specification and validation of process automation and monitoring

  • Validation of aseptic processing and sterilisation processes.

  • Compliance for computer systems, electronic records and signatures

  • Analytical/microbiological methods and equipment.

Engineering Support
  • Management of integration of GMP requirements into construction and procurement projects.

  • Quality systems management for capital projects and contractors

  • Design and management of specialist systems such as HVAC, clean rooms; critical processes and utilities and GMP impacted computerised systems.

  • Decontamination, cleaning and sterilisation systems

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