CMC Value Advisory

can facilitate the process of getting your idea into a biopharmaceutical product

CMC Value Advisory

can facilitate the process of getting your idea into a biopharmaceutical product

About CMC Value Advisory

CMC Value Advisory is an independent consultancy company and was established in March 2019 by Gunhild Klarskov Kristiansen.

CMC value Advisory utilizes 25 years+ shop floor experience to provide:

  • Support and facilitate the process from idea to a new drug product on market within CMC development
  • Bridging between development and production of new biopharmaceutical products
  • Counsel biopharmaceutical developers and Bio-investors within e.g. due diligence and CDMO/CRO selection
  • Interim capacity as project manager, CMC coordinator or scientist.

CMC Value Advisory focuses on Danish and European small/medium sized enterprises.


Drug Development
Client need:
  • Knowledge
  • Certainty
  • Risk overview & reduction
  • Prioritization and management
  • Cost efficiencies
  • Responsiveness
  • Regulatory competence
Interim capacity
  • On-site consultancy and supervision on CMC tasks in company and CDMO/CRO sites
  • On-site capacity within drug substance, drug product and analytical issues as:
  • Chemist in lab
  • Design, plan, supervise and report on method development, formulation and stability
  • Write CMC documents for regulator purpose
  • Protein characterization according to product development level
Drug and CMC Development Counselling
  • Facilitate Business Development
  • Project Management
  • CMC coordination
  • DS/DP/analysis coordination
  • Bridging between customer and CMO/CRO specialists as well as the project

Navigating through the CDMO/CRO archipelago

CDMO/CRO providers – What to be aware of
  • Development of production methologies
  • Scale-up capacity
  • GMP facilities
  • Development of quality control
  • Deliver quality controlled product for client purpose
  • Multi-facilities production
  • Several other clients
  • “Overselling capabilities”
  • Reliability


Bo Forsberg
Forsberg Biotech / NIPU Konsult HB
Development and Manufacturing of DS

Faramarz Moshfegh
CMC DP Consulting
Development and production of DP

Tram Petersen
Bellatriks Consulting
QMS and QA services

To get in touch please contact CMC Value Advisory by mail or phone or use the form below.
We are looking forward to serve you and your company.