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

Cloud Computing is speeding up the way we create, share, and view data. With features such as multiple backups, high security, remote access, and auto-scalability, this platform of virtual computing is assisting health care providers and medical devi...

If you have ever wondered exactly what role the FDA has in mammography and breast cancer screening, you are not alone. How the FDA regulates technology such as this can get complicated easily when you consider all the different aspects......

The US FDA introduced a new form of certificate referred to as the Certificate for Devices Not Exported from the US (CDNE). These certificates are for devices not manufactured in the US and hence are not eligible for export certificates......

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.

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