DRUG
DEVELOPMENT
COUNSELLING



CMC
DEVELOPMENT
SOLUTIONS



REGULATORY
AFFAIRS
SOLUTIONS



CLINICAL
OPERATIONS
SOLUTIONS



CLINICAL
TRIAL SUPPLY
SOLUTIONS



PHARMA-
COVIGILANCE
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QUALITY
ASSURANCE
SOLUTIONS


About

Our core ambition is to support our clients by advancing the progress of their drug development projects, and over the past decade, we have grown to a point, where we can offer all the necessary end-to-end expertise and competences to achieve this. It has enabled us to partner with both biotech and pharmaceutical companies and assist them in navigating the drug development process and successfully bring their products to market. Our more than 150 highly-qualified staff, all with industry experience, offer expert consulting and operational services throughout the entire drug development process.

Our solutions span all areas of drug development. No matter your need, or where you are in the drug development process, we can assemble a team of experts appropriate to the task at hand. We can support you by:

  • Providing your organisation with the right expert advice at the right time
  • Being a strategic partner throughout the entire drug development process
  • Being a reliable supplier to take care of all your project needs

Whether your organisation is pressed on time, resources or expertise, we are able to assemble a team of relevant expert consultants to assist you. We strive to build flexible and trust-based partnerships, in which we work as an integrated part of your team to deliver solutions that are not only cost-effective and compliant, but also tailored to your project-specific needs. This approach to working with our clients has deep roots in our core values.

KLIFO has operational sites in Copenhagen, Denmark and Munich, Germany.

How we work

Collaboration
At KLIFO we believe in collaboration, both internally among our staff and together with the companies we partner with. Only through collaboration is it possible to foresee and mitigate the many complexities associated with developing a new medical drug or device or bringing products to market.
Flexibility
Each and every drug development process is unique – acknowledging and embracing this is key to successfully bringing a new product to market. At KLIFO our starting point is to always listen to our clients’ needs and aspirations and based on this we can develop customised and efficient solutions.
Trust
The drug development process can take many years and the path can be costly and complex. Yet, at KLIFO we always have confidence in each other’s capacity, and this helps us to stay positive and develop novel solutions, also when faced with a difficult challenge. We have the same approach to working with our clients; building trust-based relationships plays a pivotal role in how we work.
Competence
Each milestone along the drug development journey requires unique skills and special expertise. KLIFO always strives to attract and retain the leading experts from all fields of drug development. We invest in our people and encourage their growth and development, so they can continue to offer the best possible solutions for our clients.

Key events at KLIFO

2019
Jan 30

KLIFO office established in Sweden

KLIFO acquires Munich-based medicomp GmbH

Jan 30

Quality Assurance Solutions established

2018
Nov 22

For the 4th year in a row, KLIFO receives the prestigious Gazelle prize

Nov 20

KLIFO becomes a member of Trial Nation

2017
Nov 24

KLIFO joins Danish public-private NEXT Partnership

Nov 23

CMC Development Solutions established

Nov 22

KLIFO joins the Danish public-private NEXT partnership

2015
Nov 23

Pharmacovigilance Solutions established

2014
Nov 23

Regulatory Affairs Solutions established

2008
Nov 23

Drug Development Counselling Solutions established

Nov 22

Alejandra Mørk acquires KLIFO and joins as CEO

1998
Nov 22

Clinical Trial Supply Solutions established

1997
Nov 22

KLIFO joins PSNResearch

1994
Nov 22

KLIFO is founded in Denmark as a Clinical Research Organisation (CRO)

Management team

Alejandra Mørk

CEO

Alejandra Mørk joined KLIFO in January 2008 as CEO and main shareholder. Previously, she worked for Nycomed Pharma for 18 years, in various management positions in drug development and lifecycle management.

Alejandra chairs the Danish Pharmaceutical Society, is a board member of Danish Biotech and a member of the Danish Academy of Technical Sciences. She is also part of the EUCROF Paediatric Working Group.

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

Klas Rådberg

VP

Klas holds a Master of Science degree and a PhD within Gastroenterology and joined KLIFO in March 2017. He has 16 years of experience from the clinical trial field where he has worked as project manager and clinical research director at big and mid-sized pharma companies as well as CROs. During these years, Klas has been actively involved in the delivery of more than 35 clinical trials/projects.

Christina Vinum

VP

Christina Vinum joined KLIFO in February 2011 as Senior Clinical Trial Supply Coordinator and became Director of Clinical Trial Supply in January 2012 and VP: Clinical Trial Supply in 2014. Christina has more than 15 years experience with clinical trial supplies, first at Nycomed from 2001 as Clinical Trial Supply Coordinator and, from January 2009, as Head of Clinical Supply for Nycomed CTS departments in Denmark and Germany.

Direct/mobile: +45 44 222 960

Email: moc.ofilk@muniv.anitsirhc

Anne Tingsgård

VP

Anne Tingsgård holds a Master of Pharmacy degree and joined KLIFO in September 2014. She has more than 30 years’ regulatory affairs experience from both big pharma and private consulting, including two years as CEO and COO in A-consult.

Direct/mobile: +45 44 222 940

Email: moc.ofilk@draagsgnit.enna

Michael Krak

CFO

Michael Krak joined KLIFO in February 2016 and is responsible for KLIFO’s financial management. He has solid financial experience from 25 years in positions as Controller, Finance Director and CFO in companies such as Accenture, Nycomed and Takeda.

Board of directors

Mette Kirstine Agger

Managing Partner, Lundbeckfonden Ventures

Mette Kirstine was previously co-founder and CEO of 7TM Pharma A/S and has a broad international experience within biotech/life science covering business development and licensing, management and financing.

Mette has been appointed to numerous board positions both in private and public companies. Mette Kirstine Agger graduated as Biologist from the University of Copenhagen and has an MBA.

Morten Nielsen

CEO, Nielsen Advisory

Morten Nielsen has more than 20 years of experience across various industries and have obtained extensive executable experience within fast-track turnaround, management consulting, business development, product innovation, regulatory affairs and performance management.

Morten has a master degree in electrical engineering.

Kerstin Valinder Strinnholm

Business Development Advisor and Board Member

Kerstin Valinder Strinnholm has more than 30 years experience from leading positions in sales, marketing and business development from AstraZeneca and Nycomed Takeda.

She is also active as member of the boards of Camurus AB, Corline Biomedical AB and Immunicum AB, and holds a degree in Journalism from the University of Gothenburg.