The aim for any pharmaceutical company is to submit First-Time-Right Submissions to the Health Authorities (HA) to reduce the approval timeline and go-to market as early as possible. We know that the publishing process is complex, with pharmaceutical companies using various publishing tools to both compile and publish documents in eCTD, NeeS, and paper formats as specified by the HAs. In our experience, some 70%+ of small to medium companies are still following a manual process to process and add documents to the Document Management System (DMS) and, subsequently to the Publishing tool. This is not only time consuming, but it also expends additional efforts both pre and post publishing.
Please complete the form to download a copy of Electronic Automation and Process Optimization for First-Time-Right Submissions, authored by Balaji A, Manager of Regulatory Operations, Navitas Life Sciences.
Published in Express Pharma magazine | Volume 16 | No. 8 | July, 2021 | Pages 27 - 28