For Quality and Regulatory Expertise, Trust EMMA

EMMA International is a leading global consulting firm for the medical device, pharmaceutical, biotechnology, combination products, and diagnostics industries.

With a focus on quality, regulatory and compliance services, EMMA International helps ensure your products advance seamlessly from concept to approval.

When you need specialized services, such as building a Quality Management System (QMS) or remediation of major gaps and deficiencies, EMMA’s experienced consultants will guide you toward a practical solution. We won’t leave you with a foreign process or system that ultimately becomes unworkable. Our mission is to provide significant value to your operations and exceed your expectations.

As your regulatory partner, EMMA works within your corporate culture and alongside your team. While you focus on innovation and development, you can trust us to take care of the heavy lifting that results in permanent, meaningful improvements.

To find out how EMMA International can help advance your business objectives, get in touch.

Client First

EMMA International prioritizes your needs. Your success is our success.

A Holistic Approach

EMMA International takes a holistic approach to consulting. Our engagements leverage our FDA expertise while reviewing the whole picture. We solve your short-term challenges and offer long-term solutions.


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

Full Circle Lifestyle Consulting

EMMA International delivers custom-tailored quality, regulatory, and compliance solutions across all stages of your product’s lifecycle.

Global Presence

EMMA International’s global network of experts support you during interactions with regulatory bodies worldwide. We’ve worked with clients based in the United States, Europe, Asia-Pacific, and beyond.

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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

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