Case Study: Medical Writing — NDA Submission

Regulatory submissions to health authorities offer little to no margin for error. Anything omitted or inaccurate in the documentation submitted to regulatory authorities requires extra effort and, typically, extra expense to correct — often extending project timelines and resulting in time-to-market delays.

Even pharmaceutical sponsors that retain an in-house medical writing team must outsource part or all of this critical task to a medical writing partner. Sponsors have exacting standards for these partners in terms of quality, adherence to timelines, and accessibility (to both data and vendor personnel).

This case study documents a Netherlands-based, clinical-stage pharmaceutical company’s decision to hire inSeption Group (ISG) to provide medical writing services after losing key members of its in-house medical writing team, including the lead, just a few short months before its product’s initial New Drug Application (NDA) submission to the US Food and Drug Administration (FDA).