DRUG DEVELOPMENT COUNSELLING

CLINICAL
TRIAL SUPPLY
SOLUTIONS

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

Tina Kjøller

Drug Development Consultant

Tina holds an M.Sc. in Pharmacy and for more than 30 years she has worked in the pharmaceutical industry especially within regulatory affairs and quality assurance of both drugs and medical devices. Her key competences within regulatory affairs are drugs, medical devices, drug-device-combination products, orphan drugs, and within QA she specialises in GMP/GDP audits, deviation handling, and CAPAs.
Vilhelm Tetens

Senior Medical Advisor

Vilhelm holds a Ph.D. in Science and has extensive experience in life sciences and clinical development. he has 15 years of experience with basic research and more than 20 years of clinical research experience within the pharma industry. Vilhelm has demonstrated ability to develop global clinical strategy plans to explore and support product opportunities and experience with collaboration with partners in the US, Japan and Europe.
Ira Hartling

Senior Regulatory and QA Advisor

Ira holds an MSc in Pharmacy and has significant experience with most areas of Regulatory Affairs and Quality Assurance from the pharma and biotech industry.
Kim Krogsgaard

Senior Medical Advisor

Kim is a Medical doctor, specialist in infectious diseases and internal medicine. He has comprehensive experience in clinical research, clinical trials and clinical drug development as an investigator and as sponsor representative. Holds specialist recognition with Infectious Diseases and Internal Medicine and is the author of more than 100 scientific papers.
Peter Damsbo

Senior Medical Advisor

Peter has a medical degree from Copenhagen University and has more than 25 years of experience from the life science industry and scientific research with an emphasis on clinical development of drugs and devices. He has carried projects from the preclinical phase through to worldwide registration from a clinical perspective. Peter’s medical expertise spans several therapeutic areas, including diabetes, obesity, metabolic diseases and medical devices.
Lars Kjerrumgaard

Drug Development Consultant

Lars holds an MSc in Chemistry and European Patent Attorney. He is specialised in providing IP, in particular, patent consulting to pharmaceutical and biotech companies, including for medical devices.

DRUG
DEVELOPMENT
COUNSELLING