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.