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.

Lene Schubert

Director

Lene holds a Master of Science in Organic Chemistry degree
and a Lean Six Sigma Black Belt (2014). She has more than 25 years’ experience from big pharma having worked within multiple areas of pharmaceutical development as well as global project management. Lene joined KLIFO in September 2014.

Direct/mobile: +45 44 222 912

Email: lene.schubert@klifo.com

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

Our expert staff


Jes Jacobsen

Senior CMC Expert

Jes holds a Master of Pharmacy degree and joined KLIFO in May 2017. He has more than 30 years of experience within R&D with special focus on topics related to CMC/analytical development.

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