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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.

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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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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
EMMA was there for my company when we needed it most. We were in the middle of an intense Remediation when we had an unfortunate wave of turnover. Within 2 weeks EMMA had fully staffed our site with the SMEs we needed to continue the project and hit our deadlines.
Pharmaceutical Client
EMMA International has empowered my team with a wealth of diverse and highly skilled resources, fostering a cohesive environment where talent collaborates seamlessly.
Holly Cooper
Sr. Document Control Manager,Pfizer
The team at EMMA international very quickly became a valuable strategic regulatory partner for both Inertia and our clients. The are highly knowledgeable on a wide range of medical devices, regulatory situations, and jurisdictions – and are extremely adaptable, collaborative, and a pleasure to work with.
Ray Minato
President,Inertia Product Development
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