Why do my products need to be manufactured under cGMP regulations?

The US Food and Drug Administration (FDA) has been exercising enforcement discretion for laboratory developed tests (LDTs) and is now proposing to regulate these products. Manufacturing under cGMP regulations can be a confusing, costly, and time consuming process.  By choosing Argonaut you can be assured that your products will meet all compliance requirements.  We provide quality oversight in all processes from receipt to release.  We take each client’s needs into account and work closely with you to customize a quality plan that works for you, regardless of size or complexity of project.

By |April 26th, 2016|

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