OVERVIEW

Catalent Benefits      Catalent Services

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CATALENT BENEFITS

• In-depth expertise and significant investment in talent and technologies across the entire inhalation field
• Comprehensive services that can help expedite your product from concept to market
  • Dosage form selection and technology assessment
  • Formulation development and analytical testing
  • Supplying toxicological and clinical trial materials
  • Commercial-scale manufacturing
  • Track record of regulatory success around the globe

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CATALENT SERVICES

• Dosage form development
  • Formulation selection and optimization
  • Characterization of aerosols
  • Device performance
  • Pump and container selection
  • cGMP compliance
• Product testing
  • Manufacturing validation support (process and cleaning validation)
  • In-vitro bioequivalence testing
  • Release and finished product testing
  • Particle sizing, droplet sizing and spray analysis
  • Drug and delivery assays
  • Stability studies (ICH and custom conditions)
  • Structural elucidation of drug-related impurities and degradation products
  • Extractables and leachables studies
• Clinical and commercial manufacturing
  • Complete clinical trials materials preparation in support of Phase I – IV studies for nasal dosage forms and provide seamless technology transfer to our commercial manufacturing facilities:
    • Class 10,000 space
    • Potent compound handling capabilities
    • DEA-controlled substances licenses
    • Flexible manufacturing and warehouse space
    • Customized facilities built to suit
    • Both sterile and preserved production capabilities
    • “Roll in – roll out” equipment and processes
    • Warehousing
    • Vendor qualifications