Quality

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

Regulatory

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

Compliance

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 an effort to accelerate the production of tests for COVID-19, FDA released a new guidance document that will allow for clinical laboratories and commercial manufacturers to accelerate the development of COVID-19 tests. In this guidance document, F...

Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all international inspections, it would also be temporarily halting all domestic routine surveillance inspections. This unusual move by the ag...

The effects of COVID-19 have been widespread across different parts of the medical device world, but the Digital Health sector has seen the most growth because of the pandemic. The scope of digital health includes mobile health, health information te...

SEAMLESS QUALITY MANAGEMENT

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

Testimonials

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