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

Medical Device user fees are something all medical device firms should be well acquainted with. Under the user fee system, medical device companies must pay fees to the FDA when they register their establishments and list their devices. Additionally,...

As technology advances, more and more medical devices are being engineered with multiple functions. According to the FDA, any product that has at least one medical device function and one non-device function is considered a “multiple function devic...

Currently, we live in a world driven by the 4th Industrial Revolution in which science and technology are continuously evolving. But what exactly is Industry 4.0? It is the process of using tech platforms like Cloud, IoT, AI, and Analytics......


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.


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