Whether you’re working on small or large molecules, our teams are here to support you at every stage of the development pathway.

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Formulation and Product Development

  • Developing advanced powder blend formulations, as well as aqueous (for nebulisation) and non-aqueous (for pMDI) solutions or suspension formulations for either novel or generic products
  • All phases of DPI and pMDI development for monotherapy and complex (novel or generic) combination products
  • Capability to formulate both small molecules and biologics
  • Broad portfolio of proprietary device and formulation technologies available to access
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Pharmaceutical Analysis

  • Large, experienced analytical group able to undertake the complete spectrum of test methodologies (including physical properties evaluation), required to support the development of DPI, pMDI and nebulised products
  • Comprehensive stability storage facility able to support pivotal programmes
  • Able to test products under more realistic conditions (testing with a range of throat models using electronic lung or breathing simulator)
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Device Development

  • DPI, pMDI and advanced mesh and jet nebuliser technologies available to allow optimal device selection depending on the drug substance, target disease, lung delivery targeting requirements or patient population
  • Comprehensive compliance with Medical Device Regulation (MDR) and other regulatory and quality standards
  • Also able to support the industrialisation of DPI, pMDI and nebuliser devices and products

See our technology

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Process Development, Product Manufacturing & Technical Transfer

  • Progression from feasibility through to transfer to commercial production
  • Process scaling using equipment representative of commercial production (pMDI and DPI)
  • Managing of in-market/commercial device supply though network of suppliers

All the above services are supported by our Regulatory and Pharmacovigilance team who have regulatory development and submission expertise in the respiratory area (NCEs and generics). They also have proven global regulatory success with medical devices and combination products, including compliance with MDR, and global pharmacovigilance and device vigilance capabilities.

CONTACT OUR EXPERTS

Talk to our team about how our science, technology and know-how can help your inhaled development programme.

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