COREALIS PHARMA

TECHNICAL TRANSFER AND DOSSIER SUPPORT

COREALIS Pharma performs oral dosage form manufacturing for clinical trials but the relationship with clients does not end there. COREALIS Pharma’s experts are there to assist clients by providing the appropriate drug products information required for IND/CTA submission to regulatory agencies and, if necessary, execute the transfer of the drug products and processes to a large scale manufacturing facility. These transfers are carefully planned, structured, documented, and the work is supported until final approval and the manufacturing of the commercial batches. This formulation and process transfer and scale-up can also include analytical method transfer, if the situation calls for it.