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. LDTs are likely to require cGMP in the near future, so manufacturing your product to these standards now protects you. Manufacturing under cGMP regulations can be a confusing, costly, and time-consuming process. Additionally, regulations are constantly evolving and can be difficult to keep up with on your own. By choosing Argonaut, you can be assured that your products will meet compliance requirements.