This specialty pharmaceutical company is focused on the development and commercialization of an immunosuppressant for the prevention of organ rejection in kidney transplant patients. Currently a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) and a New Drug Application (NDA) with Orphan Drug Status is under review with the US Food and Drug Administration (FDA).
Since 2011, Synchrogenix® (a Certara® company), has provided various services to this specialty pharmaceutical company in support of their recent filings to the EMA and FDA, including authoring, technical editing, document conversion, and Quality Control (QC). With simultaneous submissions, this company needed additional support to align their documents with EMA and FDA guidelines. Documents were coming at various time points from multiple authors, and the exact workload could not be defined. An ad hoc, single-source solution was needed to provide organization, ensure consistency, and adhere to regulatory requirements.