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 +15 years experience with CMC from leading pharma- and biotech 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
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