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

Last week, the FDA finalized guidance for medical device establishment inspections, which satisfies a requirement of the FDA Reauthorization Act (FDARA) of 2017. The FDARA was signed into law on August 18, 2017, and amends the Federal Food, Drug, and...

FDA released a guidance document on Monday in the form of a question and answer format to help the industry understand the implications of the pandemic on their pre-market submissions made to the FDA. As per this guidance, FDA says......

The COVID-19 pandemic has forced some of the most drastic loosening of regulatory requirements the FDA has ever done. Relaxed regulations allow quick access to critical medical devices necessary to fight the pandemic, but what will happen to the medi...

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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