Capabilities

Formulation/Process Development

• Active Pharmaceutical Ingredient (API) characterisation
• Formulation Design
• Blending and filling
• Blend characterisation

Device Development

• Device design
• Design History File compilation and maintenance
• Metrology and device testing

 Analytical

• Inhaled product testing including:
  • Aerodynamic Particle Size Distribution analysis using Next Generation Impactor and Andersen Cascade Impactor
  • Delivered Dose testing
  • Laser diffraction particle size analysis
• Method development and validation
• ICH stability storage
• Pharmacopoeial / monograph testing
• API and raw materials testing

Clinical Manufacture

• Australian Therapeutic Goods Administration (TGA) licence to manufacture products to GMP
• GMP Quality Management System
• ISO class 8 clean-room facilities
• Blending
• Precision filling of powders
• Device manufacture oversight
• Small scale device assembly

Clinical And Regulatory

• Design and oversight of PK and clinical efficacy studies for inhaled products
• Global regulatory requirements for development and commercialisation of inhaled products
• Novel clinical trial designs
• Authoring of regulatory submissions
• Engagement with Regulatory Authorities

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