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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.

Client First

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.

Partnership

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

The 10 Golden Rules for GMP Production – Part 1

The 10 Golden Rules for GMP Production – Part 1

Good Manufacturing Practices (GMP) is a system that consists of processes, procedures and documentation that ensures products are consistently produced and controlled according to set quality standards; for pharmaceutical production this is especially important. In general, there are 10 golden rules that apply in order to fulfill the GMP requirements. This article is part 1 of a 2-part series that discusses the first 5 rules and why they are important.
The eSTAR 510k

The eSTAR 510k

The voluntary eSTAR (electronic Submission Template And Resource) is a fillable portable document format (PDF) document that seeks to make 510(k) and De Novo submissions quicker and easier due to its automation from its form construction and autofill capability
Medical Device Reporting

Medical Device Reporting

Medical device reporting (MDR) is one of the post market surveillance tools used by the FDA to monitor medical devices’ performance post release (21 CFR part 803)
Artificial Intelligence and Machine Learning in Drug Development

Artificial Intelligence and Machine Learning in Drug Development

With the growth of computational capabilities, artificial intelligence (AI) and machine learning (ML) have become a beacon of interest from both the product development side and the regulatory side. Implementation of AI and ML methodologies into the day-to-day life of our society is a real and ever-growing adaptive process. The FDA has just released a document that facilitates discussion and brings about important ideas for its place in society and how it will be regulated [1]. In 2021, over one hundred submissions to the FDA included some usage of AI/ML [2].
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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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