Product development

We provide comprehensive product development services from early clinical phases to marketing authorisation, for both human and veterinary products. Our highly skilled development team can provide flexible and cost-efficient pharmaceutical development strategy to fulfil our customer’s needs.

Each project is led by a project manager according to a project specific formulation development program including:  

  • Physical/-chemical characterization of the active pharmaceutical ingredient (API) and reference listed product (RLD) (if required)
  • Formulation development according to QbD principles:
    • Essential characteristics of the drug product under development, Quality Target Product Profile (QTTP)
    • Selection and sourcing of excipients and primary packaging materials 
    • API/excipient compatibility studies
    • Identification of critical qQuality attributes (CQA)
    • Identification of critical process parameters (CPP) which may have influence on CQA
    • Process development and optimization
  • Analytical method development
  • Technology transfer and scale-up. Our experienced scientists are motivated to support manufacturing operations and to provide comprehensive documentation during the industrialization phase. 
  • Stability study services are an essential part of the complete service package

Product Development

Hard gelatin capsules

Tablets

Liquids

Suspensions

Semisolid formulations

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