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

The Emerging Medtech Summit 2020, organized by Life Science Intelligence, saw over 100 innovative medical technology startups from a multitude of medical modalities present their cutting-edge innovative technology and their plan for growth to gain st...

Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any...

How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind......

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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