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

Complaint handling can be a daunting task especially if you are a small company. 21CFR 820 requires customer complaints to be handled by a designated customer handling unit and if you are a small company this might seem a little......

Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be eligible for an expedited review pathway called the Breakthrough Devices Program. The FDA defines a breakthrough device as any device (or......

As a medical device manufacturer, every company must establish a QMS in compliance with 21CFR 820 (if you sell in the US) or ISO 13485 [which is internationally recognized]. With this as a starting point, you might have the Quality......


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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