Drug Development Plans
Manufacturing and quality programs must not only deliver clinical trial materials on time but also provide the data and information necessary to support regulatory investigational and market applications. How and when specific studies are conducted depends upon a number of factors, such as the complexity of your API, formulation, and manufacturing processes.
Applying their decades of experience with regulatory expectations and requirements for each stage of clinical development, our CMC consultants work with you to develop cost effective and efficient cGMP programs that support both financial and clinical milestones.
You receive a detailed GANTT chart that identifies key decision timepoints, milestones, dependencies and timelines required to complete studies. The resulting Drug Development Plan serves as a useful management tool to:
- Understand the implications of financial decisions
- Set timing of clinical trials
- Determine timing of regulatory filings
- Assess commercial launch implications
- Establish performance-monitoring checkpoints
Contact us for more information on how we can help with your Drug Development Plans.