CMC Drug Product Consulting
We support our clients in realizing their drug product from first human dose to commercial launch
Drug Product Development
QbD for Biotech
CMC Regulatory Writing & Advise
Data Analysis
Faramarz Moshfegh, Founder
CMC/Technical/Advice:
Formulation development
Process development
Drug product development strategy
Regulatory CMC advice
About Faramarz: Faramarz has +16 years experience with CMC from leading pharma- and biotech companies in Denmark.
Signe Christensen, Senior Consultant (external)
CMC/Strategy/Advice:
Drug/device combination product development
Regulatory CMC advice
e-CTD module 2.3 & 3
CMC technical writing
Primary packaging materials development
About Signe: Signe has +20 years experience from leading pharma and biotech companies in Denmark and US.
Mouritz N Svenson, PhD
Technical project management:
CDMO search & management
Study design & documentation
Tech transfer & documentation
Data analysis & presentation
About Mouritz: Mouritz holds a PhD in amorphous materials and has worked for a GMP-certified contract laboratory.
Aydin Mataji, Senior Consultant
QA GMP Support
NC/CAPA (SPS) process management/support
Change request process management/support
QP (Batch review and product release)
Validation activity (protocols and reports)
QMS evaluation and support
About Aydin: Aydin has +10 years experience with quality assurance and GMP from leading pharma- and medical device companies in Denmark
Toke Jost Isaksen
Consultant (external)
Development/Technical:
Cell & gene therapy
Process development
Bioassays
CDMO search
About Toke: Toke has a PhD in Medicine, and has worked with drug and process development for cell and gene therapies including viral vectors at leading pharma and biotech companies in Denmark