Second Time's The Charm — Navigating NDA Submission, Plus A Resubmission Rescue Mission

Preparation and submission of a New Drug Application (NDA) always is a multifaceted affair. However, challenges can mount quickly for a small organization just ramping up to its first NDA: it may need help in areas it had not anticipated. In the example discussed here, the biopharmaceutical company had to overcome a complex trial master file (TMF) transfer from a previous licensee, staff turnover, and a resubmission of the NDA after the initial submission was flagged by regulators.

inSeption Group (ISG) encountered challenges in serving its client, as well, stepping into various functional areas one at a time until the partnership spanned a depth and breadth of services beyond anything the organization had provided before. To date, the ongoing partnership has involved ISG’s Medical Writing, Quality Control (QC), Quality Assurance (QA), and Regulatory Operations/Publishing groups.