cGMP for your clinical batch
Find out why manufacturing best practices are critically important to your product’s transition from drug substance to human-ready clinical material.
Find out why manufacturing best practices are critically important to your product’s transition from drug substance to human-ready clinical material.
For an injectable medication, the shift from preclinical to clinical development comes with a range of new procedural, logistic, and regulatory considerations. First and foremost: how to not only produce enough of your drug substance to supply your trials, but do so in a way that meets all quality and safety standards for in-human use.
In this video, you’ll learn how and where to start aligning with key manufacturing standards for clinical material – and why an expert partner can be a critical asset during this step.
Gerhard Reuter is a veteran quality specialist who plays a critical role in authorizing the release of medical product batches, and also oversees the quality systems used to produce them.
Sign up today to get his in-depth insights on the cGMPs that matter most for clinical-stage injectable medications, and how an early focus on compliance can help support future regulatory success.
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