Clinical Regulatory Writing Submission Team

Medical/Scientific Writing

Regulatory Affairs

The Situation

A large, established pharmaceutical company was planning to submit a new drug application for a biological product to treat a rare disease. Concurrently, the company was working through a variety of corporate initiatives that—while positive—were impacting productivity, including corporate restructure, headquarters relocation, and several acquisition integrations. The company was challenged with meeting the writing needs of the clinical content of a regulatory submission while subsequently negotiating and managing the internal complexities.

The Solution

BioBridges provided a team of clinical submission writing professionals who integrated 100% into the corporate structure and focused on creating the successful clinical content for the regulatory submission.

The BioBridges team provided the following:

  • Quick ramp-up with minimum burden on the internal employees
  • Worked alongside the corporate regulatory and medical leadership to develop and implement the clinical content strategy and implementation plans
  • Developed and led the cross-functional clinical team to establish tactics for executing the clinical strategy into the clinical content
  • Wrote significant, de novo clinical content required for the clinical submission, working in seamless partnership with the internal medical and statistical leads
  • Provided all timeline and task oversight to ensure risks were understood and managed
  • Ensured the most efficient use of corporate employees’ time and support them during this stressful period of corporate initiatives
  • Tracked and managed all team activities and communications to provide an exhaustive communication trail
  • Quick ramp-down with effective transfer of the clinical product knowledge to the company’s internal team

The Results

Our client’s submission was ultimately approved by regulatory authorities with no clinical questions presented during the review process.