Enforcement Action and Compliance Consulting

Whether you received a Form 483, a Warning Letter, or any other type of enforcement action, EMMA International helps you take action.  

From assisting with corresponding with the FDA to deploying immediate help for remediation activities, EMMA International will find a timely, sustainable, and cost-effective solution.

We support projects of all sizes across the life sciences industry. Our compliance consulting services include:

  • 483 Responses
  • Warning Letter Responses
  • Remediation Strategies
  • Labeling and Website Reviews
  • Audit and Gap Analyses
  • Mock FDA Inspections
  • Remediation

EMMA International also assists with proactive post-market activities. These include:

 

  • Pharmacovigilance
  • Inspection Readiness Training
  • Subject Matter Expert Support
  • Post-Market Clinical Follow Up (PMCF)
  • Global Vigilance Support

Ready to learn more about working with us?

Post-Market Compliance Resources

Surviving A Recall

Surviving A Recall

‌  Being non-compliant in even a small detail of a regulation can result in the need to perform a recall. ...

Ready to learn more about working with us?

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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