Business solution

KLIFO CMC Development Solutions applies scientific excellence to ensure optimal development of your drug candidate. Our experts ensure that your drug presentation is suitable for the relevant pre-clinical and clinical stages. This ensures that information related to your product inspires confidence at the relevant regulatory agencies so that your drug can readily progress to the next stages of development.

Lars-Bjørn Christensen

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Expertise &
therapy areas

Expertise

At KLIFO CMC Development Solutions, we offer expert CMC consulting throughout all R&D stages including:

  • CMC project management
  • Expert support in formulation and analytical development
  • Development of quality target product profiles (qTPP) and identification of critical quality attributes (CQA’s)
  • Implementation of Quality by Design (QbD) in drug development
  • Performing and facilitating root-cause investigations
  • Upscaling of manufacturing processes and transfer to CMO, including management of CMOs
  • Preparation of reports and documentation to support regulatory filings
  • Planning and conducting of CMC due diligence (DD), including reporting and recommendation
  • Medical devices:
    • Drug-device combinations
    • Container closure selection

Our expert staff