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.

Hanne Wulff Nielsen

VP

Hanne holds a Ph.D. in biopharmaceutics and has more than 25 years of pharma industry experience within pharmaceutical product development, business development, project and vendor management, marketing and medical affairs. She joined KLIFO in January 2019 and prior to this she has held specialist and leadership positions in large pharmaceutical companies and in biotech.

Direct/mobile: + 45 44 222 903
Email: moc.ofilk@neslein.ennah

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
  • Medical devices:
    • Leading both medical device only and drug-device combination development projects
    • Strategic project management from ideation to pilot production to registrations
    • Medical device development strategy
    • Due diligence of device projects
    • Medical support to device development

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


Senior advisors


  • Carsten Roepstorff (DK)
  • Charlotte Videbæk (DK)
  • Christine Felding (DK)
  • Cordula Wolf (DE)
  • Gabor Liposits (DK)
  • Inger Christine Munch (DK)
  • Jan Harry Petersen (DK)
  • Klaus Stöhr (DE)
  • Lars Jelstrup Petersen (DK)
  • Maria Bech (SE)
  • Mikael Thomsen (DK)
  • Peter Nissen Bjerring (DK)
  • Stig Waldorff (DK)
  • Ulrik Mouritzen (DK)
  • Achim Orzechowski (SE)
  • Andrew Makin (DK)
  • Annsofi Nihlen (SE)
  • Geertje Lewin (DE)
  • Ingrid Bøgh (DK)
  • Line Hartvig (DK)
  • Martin Munk (DK)
  • Roman Föll (DE)
  • Christina Mørk (DK)
  • Hanne Jensen (DK)
  • Henrik Tønsberg (DK)
  • Mette Theilade (DK)
  • Gertrud Schuster (AT)
  • Hanne Bendixen (DK)
  • Peter Bergqvist (SE)
  • Anders Vagnø Pedersen (DK)
  • Babak Jamali (DK)
  • Jens Bukrinski (DK)
  • Jørgen Lang Pedersen (DK)
  • Julia E. Diederichs (DE)
  • Kaare Gyberg Rasmussen (DK)
  • Kaare Lund (DK)
  • Karen Rørbæk (DK)
  • Karin Liltorp (DK)
  • Lars Foldager (DK)
  • Lars Gyldenvang (DK)
  • Marianne Svärd (SE)
  • Mats Reslow (SE)
  • Timo Schmidt (CH)
  • Anders Nyberg, GCP (SE)
  • Siglinde Duerr, GMP (DE)
  • Tine Jørgensen (DK)
  • Thomas Bengtsson (SE)
  • Lars Bo Kjerrumgaard (DK)
  • Hans Mosberg (DE)