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

On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / Machine Learning (AI / ML) based Software as a Medical Device (SaMD) and is taking public comments on the proposal until June 3, 20191. T...

Does a Human Factors/Usability Engineering (HFE) validation study need to be completed for your medical device?  If your Risk Management process is not integrated with HFE, how and when to integrate it into the product development process can be imp...

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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