Business solution


KLIFO Drug Development Counselling increases the value of development projects and operational strategies by bringing together a wide range of expertise across all key R&D functions to support our clients’ decision making. Based on thorough, data-driven assessments we help you to build robust drug development strategies.

Michael Engsig

EVP

Michael Engsig is a broadly anchored pharmaceutical professional with more than 19 years of experience and successful track record in R&D and commercial functions. When joining KLIFO in January 2017 he came from a position in PPD as Head of Central and Eastern Europe Clinical Management.

Direct/mobile: +45 44 222 913

Email: michael.engsig@klifo.com

Expertise &
therapy areas


Expertise

  • Product development strategies and plans (overall, clinical, preclinical, CMC, regulatory)
  • Documents for regulatory purposes (efficacy, safety, quality)
  • Documents for planning and decision-making (project plans, TPPs, risk assessments, gap analyses, second opinions)
  • Scientific advice/pre-IND (LoQ, briefing documents, facilitate meetings with authorities)
  • Due diligence of projects and portfolios
  • Interim experts (medical, clinical, preclinical, CMC, QA, biostatistics and regulatory)
  • Interim project management, alliance management and R&D management.
  • GCP Audits – site and CRO/Vendor audits. Support to optimizing your GCP Quality Management System.
  • Medical writing
  • Biostat
  • Clinical CRO qualification, negotiation and oversight

At KLIFO Drug Development Counselling, we offer our services across a wide range of therapy areas including:

  • Oncology
  • Immunology
  • Neurology
  • Psychiatry
  • Cardiology
  • Diabetes
  • Gastroenterology
  • Respiratory Pain
  • Infectious diseases
  • Haematology

Our expert staff


Thomas Matthiesen

Project Director

Thomas holds a Master of Science in Chemistry and Cell Biology degree. He joined KLIFO in October 2015 with more than 15 years of experience with managing development projects within the pharmaceutical area.

Michael Gerstenberg

Project Director

Michael holds a Ph.D. in Physics and a Master of Science in Engineering degree. He joined KLIFO in 2017 after 15 years in device and drug research and development at Novo Nordisk, most recently as scientific director and research project director. Michael has primarily worked within diabetes and obesity, but his focus now is on advanced therapeutic medicinal products, especially within immuno-oncology.

Anders Vagnø Pedersen

Senior CMC Advisor

Martin Munk

Senior Non-clinical Advisor

Charlotte Videbæk

Drug Development Consultant

Charlotte holds a Doctor of Medicine degree and is a board certified Neurologist. She has worked internationally with drug development both as line manager in large pharma companies and as CEO for small entrepreneurial biotechs.

Anders Nyberg

Drug Development Consultant

Anders Nyberg joined KLIFO in December 2018. He is an experienced and well-known capacity in the clinical QA field and has a long track record in audits and inspections within GCP, vendors, phase 1 units, and subsidiaries.

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