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? Our team of seasoned experts is available 24/7.
Ready to learn more about working with us?
Post-Market Compliance Resources
Founded in 2008, “October 15 is Global Handwashing Day a global advocacy day dedicated to increasing ...
Being non-compliant in even a small detail of a regulation can result in the need to perform a recall. ...
Post-Market Surveillance (PMS) is a common part of Medical Device Regulations across the world. Most ...
Health Canada recently published SOR/2020-262 amending the Food and Drug Regulations and the Medical Devices ...