We in 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

In contrast to 2014, news on the Ebola virus today is relatively minimal. However, Ebola outbreaks are still occurring, most recently in the Democratic Republic of Congo. This article reviews the response of the U.S. FDA to the Ebola virus and progra...

FDA is not the only organization that can review 510(k) submissions. Under the Third Party (“3P”) Review Program, 510(k) submitters can voluntarily send their 510(k) to recognized organizations (“3PROs”) for review. This article provides an o...


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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