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Formulation Development

We offer a wide range of product development services, including:

Pre-formulation

  • Drug substance characterisation
  • Excipient compatibility studies

Formulation Development

  • API Fills
    • API in capsule shells
    • API in bottle
    • Instruction for reconstitution
    • In-use stability
  • Development of capsule & tablet formulations
    • Blending process investigations
    • Optimisation of composition (filler, disintegrant, lubricant)
    • Manufacture & testing of stability batches
  • Micro-suspension systems
    • Surfactant and polymer screening
    • Spray drying / spray granulation
    • Formulation optimisation (e.g. suitable for capsule filling)
  • Solubilised systems
    • Solubility screening
    • Formulation optimisation (e.g. suitable for capsule filling)

Clinical Manufacturing

  • Manufacturing and release testing of phase I, II and III drug product
  • Stability services according to ICH guidelines
  • CMC support

Process Optimisation

  • Process scale-up
  • Process validation
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Translating science to targeted patient care
Supporting the development & supply of APIs
Clinical supply; manufacturing; packaging; distribution; QP
IVR; IWR; EDC; ePRO; Biostatistics
Product Development, Commercial Manufacturing, Packaging and Support