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.

From strategy to execution, EMMA delivers turnkey solutions with global expertise across every initiative.

Resources

The 513(g) Process

The 513(g) Process

Classification of certain medical devices may be predisposed to ambiguities related to which classification type ...
Complaint Management

Complaint Management

Complaint management systems are a necessary part of a Quality Management System. Complaint management is defined ...
Data Integrity

Data Integrity

Every company knows the importance of maintaining accurate and complete data of a high quality over periods of ...
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