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
Senior advisors
- Anders Vagnø Pedersen (DK)
- Babak Jamali (DK)
- Jens Bukrinski (DK)
- Jørgen Lang Pedersen (DK)
- Julia E. Diederichs (DE)
- Kaare Gyberg Rasmussen (DK)
- Kaare Lund (DK)
- Karen Rørbæk (DK)
- Karin Liltorp (DK)
- Lars Foldager (DK)
- Lars Gyldenvang (DK)
- Marianne Svärd (SE)
- Mats Reslow (SE)
- Timo Schmidt (CH)