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: moc.ofilk@gisgne.leahcim

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