Advent Pharma
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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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  • Home
  • Overview
    • The Company
    • Board Of Directors
  • Projects
  • Capabilities
  • Contact Us