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
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Post-Market Compliance Resources
Last week the FDA approved the first over-the-counter birth control drug. Opill, manufactured by Perrigo, is the first daily oral contraceptive that will be available without a prescription. The main constituent of Opill, Norgestrel, was originally approved for prescription use in 1973. The switch from prescription only to over the counter can sometimes be a complicated process, needing to take into account a variety of risks that the drug poses to public health. With the switch from prescription only to OTC, many other firms are beginning to review the possibility and implications of switching their own products from prescription to OTC.
Bingham Farms, MI, July 13, 2023 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting, has achieved ISO 9001:2015 recertification for its quality management system (QMS). Obtaining ISO 9001:2015 recertification reinforces EMMA International’s commitment to continuing to be a global powerhouse in FDA compliance consulting by consistently meeting and exceeding the expectations of our clients.
The Food and Drug Administration (FDA) utilizes regulatory standards developed by non-governmental organizations as regulatory criteria for medical devices, these are referred to as recognized consensus standards [1]. Examples of some of the organizations that develop these standards are: International Organization for Standardization (ISO) standards, American Society for Testing and Materials (ASTM) standards, American National Standards Institute (ANSI) standards, International Electrotechnical Commission (IEC) standards, etc. The IEC is an organization that develops standards to standardize the electrical and electronic fields [2].
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