Setting and adhering to a timeline for planning, drafting, reviewing and editing regulatory documents needed for the submission dossier is a major challenge for drug development teams. The most common submission planning pitfalls include:
- Missing the opportunity to learn and discuss everything possible at the beginning
- Scheduling summary document preparation in parallel with source document preparation
- Not engaging all stakeholders in developing the submission
Keeping submission timelines on track can be further compounded when sponsors try to develop simultaneous global submissions. The consequences of a chaotic submission process include wasted time and money, employee burnout, and a suboptimal dossier.
How can teams facilitate the submission process?
This white paper defines best practices for establishing submission timelines that won’t change, addresses regional differences to minimize document re-work when submitting to multiple countries, and identifies leadership and project management skills helpful to regulatory writing.