Business solution


KLIFO Drug Development Counselling provides experience, competence and strategic leadership to maximise the value of drug and device development projects.

We build and execute optimal plans based on a thorough understanding of the projects.

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
  • Drug device combinations

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)
  • 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)
  • Ulrik Mouritzen (DK)
  • Achim Orzechowski (SE)
  • Andrew Makin (DK)
  • Annsofi Nihlen (SE)
  • Geertje Lewin (DE)
  • Ingrid Bøgh (DK)
  • Line Hartvig (DK)
  • Lotte Martoft (DK)
  • Roman Föll (DE)
  • Hanne Jensen (DK)
  • Henrik Tønsberg (DK)
  • Mette Theilade (DK)
  • Hanne Bendixen (DK)
  • Anders Vagnø Pedersen (DK)
  • Babak Jamali (DK)
  • Erik Steffensen (DK)
  • Finn Wiberg (DK)
  • Jens Bukrinski (DK)
  • Julia E. Diederichs (DE)
  • Kaare Gyberg Rasmussen (DK)
  • Kaare Lund (DK)
  • Karen Rørbæk (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)