CMCAssist
Our CMC Development Solutions applies scientific and regulatory excellence to ensure optimal development of your drug candidate, from lead selection through preclinical, phase I and phase II.
Services
CMC Strategy
- IP
- Timelines
- Manufacturing
CMC writing
- IMPD
- IND
- Briefing documents
CMC Development
- Preformulation & Characterization
- Comparability & Stability
- Tox formulation & Formulation for clinical use
- Liquid
- Iyo
- Troubleshooting
Achievements
Regulatory
Documents
Formulations
Bioinformatic
characterizations
Proteins
Peptides
Other Biologics
Collaborators
The Team
Jens Thostrup Bukrinski
CEO & Founder
18 years in drug development, 10 years in academia & formerly employed at Novozymes and Novo Nordisk. I’ve worked with a total of 30+ drug development projects and put 5 drugs on the market. Extensive knowledge in the areas of peptides, proteins, mAbs, ADCs, small molecules, cancer, cardio vascular, metabolics, haemophilia, personalized medicines, vaccines & inflamation. Currently involved with CMC & regulatory strategy.
Malin Persson
Senior Advisor
9 years in drug development and 10 years in academia. Formerly employed at Maxygen & Novo Nordisk, where I’ve worked with peptides, proteins, mAbs, haemophilia, metabolics, inflammation, cardiovascular. Furthermore extensive knowledge in areas of biophysics, characterization, formualtion development, CMO & CRO management & CMC writing.
Alexander Strøm-Hansen
Bioinformatic Research Scientist
Multiple years of experience with bioinformatics & python programming. I’ve performed various in-silico analyses including protein modelling, characterizations & simulations. Addtionally, I’ve built CMC regulatory templates, aided in regulatory documentation, & been involved with project management & VC funding.
Lotte Leick Jørgensen
Senior Advisor
10 years at the Laboratory of The Danish Medicines Agency(DKMA) & 5 years in academia. My experiences at DKMA is in regulatory control of biological medicinal drug products available on the Danish marked regarding quality & documentation. I have knowledge of regulatory guidelines, QA/QC & working according to a quality system.
- COPENHAGEN, DENMARK, Ole Maaløes Vej 3
- (+45) 29 62 42 62
- info@cmcassist.dk
- CVR: 3785 0861