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

OTC Birth Control and the Regulatory Impact

OTC Birth Control and the Regulatory Impact

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.
EMMA International Consulting Group, Inc. Achieves ISO 9001:2015 Recertification

EMMA International Consulting Group, Inc. Achieves ISO 9001:2015 Recertification

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.
IEC 62304: Medical Device Software Life-Cycle Processes

IEC 62304: Medical Device Software Life-Cycle Processes

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].

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
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

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