FDA Compliance Consultants | FDA Consulting Firm

Quality

We design, build and implement Quality Management Systems (QMS) for organizations of all sizes across the Life Sciences industry.

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Regulatory

We deliver high quality, cost-effective solutions by accelerating the regulatory approval process for firms in the Life Sciences industry.

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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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Ready to talk?

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

Making Blood Donation Applications Smart Using Cloud Computing and IoT

We reside in a modern world where digital health services are available and can be accessed online instantly. Despite the apparent abundance of resources, there are still cases where hospitals or blood banks run out of essential resources, such as......

15 January, 2021 / No comment

Celebrating National Pharmacist Day

January 12th is celebrated as National Pharmacist Day to recognize all the pharmacists across the nation. In addition to surgeons, nurses, and paramedics, this is another profession that contributes immensely to the health care industry. Historically...

12 January, 2021 / No comment

FDA’s STeP Program

The FDA’s Breakthrough Devices Program is for certain medical devices that provide treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.1 This particular pathway is reserved for devices with unique and oth...

11 January, 2021 / No comment

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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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Testimonials

Carmine is one of the best in the Industry for Quality and Compliance in the Medical field. He is extremely knowledgeable with Quality and FDA procedures and has successfully implemented projects helping businesses with their challenges and pain points. I am highly impressed with his operational skills and his ability to integrate quality standards with improved methodology and efficiencies.
Yoel Yohan Partner-The Progress Group & Author of "The Corporate Drain"
Our engagement of E.M.M.A. International Consulting Group was a pleasant departure from my experience of a typical consulting relationship. Carmine and I worked together to set the goals, timetable and budget for the project early on. He kept me apprised of our progress on a regular basis and there were no surprises. We accomplished our goals on time and on budget.
Mark Drolet President, Premiere Packaging Inc.
It’s hard to find a company you can trust. E.M.M.A. International Consulting Group Inc. was recommended to me by a friend, and now I know why – the quality of service I received was outstanding. We now have a world-class quality system.
Mitchel Lansing Director of Corporate Advancement, Akron Industries
EMMA International is truly an industry expert and has patiently worked with us by assisting us in gaining a better understanding of FDA guidance and requirements.... This has dramatically improved our confidence in this area. EMMA International has also assisted us with multiple other projects such as supplier agreements and product labeling. They have been a pleasure to work with. EMMA International understands the needs and constraints of a new small business which we found to be very unique. I highly recommend the services of EMMA International.
Nancy C. Stamps, RN, President
E.M.M.A. International met the tough challenge of replacing a less than robust ISO 9001 system and developing / implementing an integrated Quality Management System. New Concept Technology was recently certified to ISO 9001, ISO/TS 16949 and ISO 13485, at both our US and Mexico facilities, based on our new integrated QMS.
Thomas Baughman, CEO New Concept Technology, Inc.