How to Avoid Last Minute CMC Roadblocks to Approval
There are many approaches to CMC:
- You can provide complete support to both clinical and CMC development, keep everything up to date at all times, and verify or investigate everything. Due to this, you may run out of funding or be last to market.
- You can wait until the last minute, scramble, and hope for the best.
- Or you can progress with clinical development, while giving metered attention to the CMC issues that pose the greatest danger of requiring costly, late-stage remediation.
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