Drug Development Project Checklist
This is a practical guide to building a project checklist for a drug development project — a step-by-step checklist covering the project from start to finish, adapted to the realities of developing a pharmaceutical product through regulatory stages.
What a Project Checklist is
A project checklist is a step-by-step checklist covering the project from start to finish. For the full concept and how it works in general, see Project Management Checklist. On a drug development project it plays the same role, tuned to this kind of work.
Why it matters for a Drug Development project
Drug Development projects live or die on developing a pharmaceutical product through regulatory stages. A well-built project checklist gives the team a shared, explicit reference for exactly that — reducing ambiguity, aligning stakeholders, and making problems visible early enough to act. Skipping it, or doing it generically, is how drug development projects drift into avoidable delay and cost.
What to include
- Initiation checks
- Planning checks
- Execution checks
- Closure checks
Drug Development-specific considerations
Tailor the project checklist to the risks that most often derail drug development projects:
- Regulatory approval delays
- Trial/validation failures
- Strict GxP compliance
Example
On a real drug development project, the project checklist would be shaped by developing a pharmaceutical product through regulatory stages. In particular, it should explicitly account for the project’s biggest risks — regulatory approval delays, trial/validation failures, strict GxP compliance — rather than treating them as afterthoughts.