CMC & Regulatory Strategy
CMC & Regulatory Strategy
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Successful development requires alignment between science, manufacturing realities, and regulatory expectations. We help teams develop clear, phase-appropriate CMC plans that support IND and NDA readiness.
How We Support Your Program
How We Support Your Program
✓ IND-enabling CMC strategy
✓ NDA planning & Module 3.2.S authoring
✓ Regulatory documentation review and support
✓ CMC risk assessment and mitigation planning
✓ Lifecycle CMC strategy from early to commercial phases
Typical Outcomes
Typical Outcomes
✓ Clear strategic path to IND/NDA milestones
✓ Strong communication with regulatory agencies
✓ Robust data packages that withstand review
✓ Reduced delays and costly rework
When to Engage
When to Engage
✓ Early development planning requiring CMC clarity
✓ Preparing IND or NDA submissions
✓ Reviewing CMC readiness before investor or partner due diligence
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