Chemistry, Manufacturing and Controls (CMC)

Pharma IT offer Chemistry, Manufacturing and Controls (CMC) consulting services to support drug development and support of marketed products.

  • CMC project management
  • Formulation support and analytical development
  • Development of quality target product profiles (qTPP) and identification of critical quality attributes (CQA’s)
  • Scaling of manufacturing processes, (tech) transfer to and management of Contract Manufacturing Organisation (CMO)
  • Preparation of reports and documentation to support regulatory filings
  • Quality Assurance of the manufacturing process
  • Qualified Person services for release of finished and semi-finished products

If you need support don’t hesitate to contact us.

Meet the Chemistry, Manufacturing and Controls (CMC) team:

Chemistry, Manufacuturing and Control (CMC) Consultant
Torben Elhauge

Holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area

With an offspring in Analytical development, Torben has a broad experience within all parts of the CMC area from development over validation and registration to GMP release of products.

Torben is experienced in working with Impurities, Stability, Specifications, Release of Investigation Medicinal, CRO’s and Tech Tranfer. Torben have assessed registration files at the Danish Medicines Agency and have written the analytical part of the registration file for several products.

Torben holds a master’s degree in chemical engineering.

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