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
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
