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The Advantage of Expertise

EMMA International is a leading FDA compliance consulting firm. We provide cost-effective solutions for FDA regulatory affairs, compliance services, quality systems, remediation, regulatory filings and submissions. Our expertise includes medical devices, biotechnology and pharmaceutical industries.

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EMMA International always prioritizes their clients’ needs and believes that their clients’ success is the firm’s success.

A Holistic Approach

EMMA International always takes a holistic approach to engagements with a strong emphasis on their FDA expertise. Beyond solving the immediate short-term challenges, we consider other hidden or future issues.

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EMMA International’s in-house team fully integrates with the client’s stakeholders ensuring a close partnership and seamless management of the client’s most complex challenges.

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Resources

Understanding Biosimilar Products

Understanding Biosimilar Products

A Biosimilar is essentially a biologic product that is similar and has no clinically significant difference in terms of safety, purity, and potency from an existing approved Biologic on the market.
The FDA and AI/ML in Medical Devices: Navigating the Future of Healthcare

The FDA and AI/ML in Medical Devices: Navigating the Future of Healthcare

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing healthcare, offering unprecedented opportunities to improve patient outcomes, streamline processes, and enhance diagnostic accuracy. As AI and ML continue to make significant strides in the medical field, the U.S. Food and Drug Administration (FDA) plays a pivotal role in regulating these innovations. In this blog post, we'll explore the intersection of AI/ML and medical devices, and how the FDA is navigating this rapidly evolving landscape.
The FDA’s Update to Biocompatibility Guidance

The FDA’s Update to Biocompatibility Guidance

The FDA’s guidance document on the use of ISO 10993-1 was updated this month with some crucial information for medical device manufacturers. Biocompatibility testing has been a long-standing requirement for a majority of device manufacturers, so this update that includes some excluded materials and devices is a welcome change.
Mastering the Art of Medical Device Design Controls

Mastering the Art of Medical Device Design Controls

Effective design controls are fundamental to producing safe and effective medical devices. They not only help ensure regulatory compliance but also contribute to the overall quality and reliability of the product. Continuous improvement and a commitment to robust design control processes are essential for success in the medical device industry.
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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.
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. They 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.
Nancy C Stamps
President, RN
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
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.
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
Author of "The Corporate Drain", The Progress Group
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