Key Highlights:
- Having industry experts conducting regulatory assessments is important to prevent overlooked issues that could lead to costly delays in gaining certified approval.
- Customised studies help identify potential degradation pathways and mitigate risks to patient safety, allowing manufacturers to implement necessary adjustments before market release and support product improvements.
- Robust and accurate methodology from early phase development builds quality into the product but allows for consistency over batches, strengths and other variable aspects.
Broughton