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.
Phone: +45 44 222 903
Email: hanne.nielsen@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
- 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
Kim Krogsgaard
Senior Medical Advisor
Kim, MD, DMSc has more than 40 years of broad clinical development experience.
Kim joined KLIFO in 2014 and works with strategic drug development and development programmes from pre-clinical to early and later clinical stages in collaboration with non-clinical and regulatory experts as well as PK specialists and biostatisticians.
Kim’s experience spans multiple therapeutic fields and drug classes including small molecules, peptides, biologics, oligonucleotides, vaccines and stem cells and includes multiple interactions with FDA, EMA and national European regulators.
Kim has served in positions as chief medical officer, medical director, medical lead, senior medical advisor, sponsor’s medical expert and sponsor’s medical monitor.
