We design, build and implement Quality Management Systems (QMS) for organizations of all sizes across the Life Sciences industry.


We deliver high quality, cost-effective solutions by accelerating the regulatory approval process for firms in the Life Sciences industry.


We provide sustainable solutions for FDA regulations and help organizations in the Life Sciences industry in the US and internationally.

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EMMA International is a leading FDA compliance consulting firm. We provide cost-effective solutions for FDA regulatory affairs, compliance services, regulatory filings and submissions. Our expertise includes medical devices, biotechnology and pharmaceutical services.

We’d love to talk to you about how we can help your business succeed.

News from EMMA INternational

The FDA released two final rules surrounding the classification, and the requirement to submit a pre-market notification, for some medical devices. The final rule that went into effect on December 30,2019 adds to the current list of class I and......

Recently, 3D printing technology has seen a boom in popularity among many different industries, including medical devices. 3D printing medical devices allow manufacturers to easily create devices that function with a patient’s anatomy (also known a...

The transition to the new EU MDR and IVDR tops the list this year with the concerns and confusion it continues to create within the industry. With a limited number of guidance documents to guide the device makers, companies are......


Imagine all the advantages of going paperless. Even more, imagine streamlining your Quality Management System. QualiPro is an Enterprise Quality Management Software (EQMS) provided only by EMMA International. QualiPro is the road to compliance for firms in the Life Sciences industry.

The Numbers Speak For Themselves

Over 2,820 Life Science Companies
Over 100 languages and over 80 countries
Over 70,000 users
Over 60.2 million dollars saved


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