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

Reporting Adverse Events

Reporting Adverse Events

Post-market surveillance is necessary for ensuring compliance as regulatory bodies have the authority to impose ...

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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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