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

Companies are often in doubt about outsourcing Internal Audits especially when they have an in-house quality assurance department. For small and medium-size companies, it might be a burden on their financial resources, however it is the right approac...

If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 states that every class III and class II medical device manufacturer “shall establish and maintain procedures to control the design of......

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......


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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