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.