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

One of the paradigms of the next generation computing tools is Augmented Reality (AR) where animated objects are superimposed on real-world objects. A live video or an image is initially scanned, detected, analyzed, and the required animated objects ...

Few people outside of the industry know how big of a role the FDA has in product labeling and packaging. Every product approved by the FDA has very specific guidelines for its packaging and labeling, and these guidelines are often......

The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in turn allows similar devices to leverage the De Novo device as a predicate. In recent years, the De Novo pathway has proven to become much.....

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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