Product/Service

COREALIS Manufacturing

Source: Ropack, Inc.

Manufacturing
COREALIS Pharma takes charge of the manufacturing of tablets and capsules for clinical trials, the submission to regulatory agencies, and, if necessary, performs the transfer of the products and processes to a large scale manufacturing site.

COREALIS Pharma takes charge of the manufacturing of tablets and capsules for clinical trials, the submission to regulatory agencies, and, if necessary, performs the transfer of the products and processes to a large scale manufacturing site. These transfers are carefully planned, structured, documented, and the work is supported until final approval and the manufacturing of the commercial batches. The professionals at COREALIS Pharma excel at troubleshooting, identifying and controlling the steps and parameters critical to the manufacturing of a pharmaceutical product that does not conform to specifications.

Services

  • Manufacturing of R&D batches to reduce development time
  • Transfer of products and processes
  • Scale-up of manufacturing processes for the production of clinical batches, submission batches, or commercial batches
  • Troubleshooting
  • Manufacturing of clinical batch
    • Manufacturing of clinical batches for exploratory studies (IND)
    • Manufacturing of clinical cGMP batches for phase I, II, and III and bioequivalence studies
    • Manufacturing of cGMP batches for submission to regulatory agencies
    • Manufacturing of cGMP placebos identical to the active products

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