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
Bingham Farms, MI, July 13, 2023 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global ...
The Food and Drug Administration (FDA) utilizes regulatory standards developed by non-governmental organizations ...
Post-market surveillance is necessary for ensuring compliance as regulatory bodies have the authority to impose ...
Providing a quality product while meeting all quality standards set by regulatory bodies can often prove to be a ...