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, FounderDevelopment/Strategy/Advice:Formulation developmentProcess developmentDrug product development strategyRegulatory CMC adviceAbout Faramarz: Faramarz has >12 years experience with CMC from leading pharma- and biotech companies in Denmark.

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 ConsultantDevelopment/Strategy/Advice:Drug/device combination product developmentRegulatory CMC advicee-CTD module 2.3 & 3CMC technical writingPrimary packaging materials developmentAbout Signe:  Signe has +20 years experience from leading pharma and biotech companies in Denmark and US.

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