Manufacturing and DISTRIBUTION 

Consulting

Good Manufacturing Practices (GMP) change frequently. Partnering with a global compliance expert will ensure your manufacturing processes stay in compliance with Current Good Manufacturing Practices (cGMP).

EMMA International helps your organization implement and maintain the appropriate processes to support cGMP compliance for the highest level of product quality, safety, and strength. Backed by decades of cGMP experience, EMMA International has the experts on hand to not only manage your compliance project, but also facilitate manufacturing runs and remediate existing operations.

Contact us to find out how we can help your compliance needs.

Our Medical Device CMO

EMMA International proudly partners with New Concept Technology (NCT), a single-source supplier that offers expert design, engineering, process development, fabrication, and manufacturing services. NCT’s facility has a state-of-the-art class 100K clean room that is ISO 1464-1 Class 8 Certified. NCT is considered an expert in medical assembly. They also specialize in medical cable over-molding and medical process automation.

Ready to discuss your next project? Get in touch.

Ready to learn more about working with us?

Resources

Microbiological Testing

Microbiological Testing

Many microbes are harmless to humans, but some can cause serious health problems. Microbes can spoil food, ...
Reporting Adverse Events

Reporting Adverse Events

Post-market surveillance is necessary for ensuring compliance as regulatory bodies have the authority to impose ...
Label Changes and the 510k

Label Changes and the 510k

Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device ...
CE Marks under IVDR

CE Marks under IVDR

The COVID-19 pandemic has changed the world by disrupting global supply chains and impacting human health. This ...

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