CMC DEVELOPMENT SOLUTIONS

CLINICAL
TRIAL SUPPLY
SOLUTIONS

Business solution

KLIFO CMC Development Solutions applies tailored scientific excellence to ensure optimal development of your drug or device candidate.

The result is that all documentation related to your product inspires confidence at the relevant regulatory agencies, enabling your project to readily progress to the next stage of development.

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

At KLIFO CMC Development Solutions, we offer expert CMC consulting throughout all R&D stages including:

CMC project management
Expert support in formulation and analytical development
Development of quality target product profiles (qTPP) and identification of critical quality attributes (CQA’s)
Implementation of Quality by Design (QbD) in drug development
Performing and facilitating root-cause investigations
Upscaling of manufacturing processes and transfer to CMO, including management of CMOs
Preparation of reports and documentation to support regulatory filings
Planning and conducting of CMC due diligence (DD), including reporting and recommendation
Drug device combinations

Our expert staff

Jørn Drustrup

Senior CMC Expert

Jørn holds a Master of Pharmacy. Furthermore, a PhD degree within the area of Drug Delivery via Prodrugs. Jørn joined KLIFO in August 2019. He has more than 33 years of experience with special focus on early stage R&D/CMC-related topics, including formulation, alternative drug delivery concepts and the interrelationship between formulation and administration devices.
Susanne Boysen

Senior CMC Expert

Susanne has a Master in Biomedicine and joined KLIFO in June 2024. She has more than 20 years of experience from a Contract Manufacturing Company (CMO), the pharmaceutical industry and several biotech companies. Over the years, she has worked in drug discovery, all stages of drug development, and supported the commercial stage as Subject Matter Expert (bioanalysis, analytical development including bioassays, producing product specific host cell assays, regulatory filings etc.) and as project- and people manager.
Helle Weibel

Senior CMC Expert

Helle holds a Master of Science in Pharmacy and a Ph.D. degree within the area of Biopharmacy. Helle joined KLIFO in November 2022. She has worked with proteins, peptides and small molecules for approximately 40 years in biotech and pharmaceutical companies. She has worked as drug product responsible with early stage formulation development, commercial manufacture, regulatory affairs and CMC project management. The administration forms in concern have primarily been: Injections (freeze dried and solutions), oral dosage forms (freeze dried and conventional) and topical products for transdermal use.
Jes Jacobsen

Senior CMC Expert

Jes holds a Master of Pharmacy degree and joined KLIFO in May 2017. He has more than 30 years of experience within R&D with special focus on topics related to CMC/analytical development.

Senior advisors

View all(14)

Senior Advisors

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)

CMC DEVELOPMENT
SOLUTIONS

SCIENTIFIC EXCELLENCE
FOR OPTIMAL DRUG DEVELOPMENT

EXPERT CMC CONSULTING EVERY STEP OF THE WAY

DRUG
DEVELOPMENT
COUNSELLING