Consulting (CMC)

CONSULTING SERVICES to biotech companies

The development of a new pharmaceutical drug product involves three different scientific activities; Preclinical Research, Clinical Trials and CMC Development. “CMC” means “Chemistry – Manufacturing – Control” and it is the name used by the authorities for the product and process development needed before a new pharmaceutical drug product can be manufactured in large scale. The CMC development starts already in the preclinical phase, continue in parallel with the clinical trials, and don’t stop before the new drug product has been approved by the authorities.

I can help you with CMC development during all phases of your project:

1) Input to the first business and development plans

2) Coordination of all CMC activities.

3) Outsourcing: CMO selection, process transfer, API manufacturing, GMP stability studies, formulation development, quality control, drug product manufacturing, clinical trial supplies and regulatory documentation