E.M.M.A. International Company Overview
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Transcript of E.M.M.A. International Company Overview
©E.M.M.A. International Consulting Group, Inc. 1
E.M.M.A. International Consulting Group, Inc.Excellence │ Multidimensional │ Methodical │ Analytical
TAKING MANAGEMENT CONSULTING TO A WHOLE NEW LEVEL
E.M.M.A. International – your one stop shop for all of your quality and compliance needs
COMPANY OVERVIEW
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Company Overview• E.M.M.A. International Consulting Group, Inc. is a
global leader in management consulting services.
• Headquartered in Farmington Hills, MI
• Focusing on quality systems, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, Medical Device and all other FDA regulated industries
• We provide support for all sizes of companies, from start-ups to multi-national corporations
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Our Management Team
Carmine Jabri, PhD, MSQM, MHA President & CEO
Kira Jabri, MPH, MSWVice President & COO
Janet Bloom, PMPVice President of Business Development
Mariam Alboustani, RPHDirector of Clinical Affairs
Click here for complete bios
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Our Consulting Team• E.M.M.A. International Consulting Group, Inc. is comprised of
seasoned consultants who are strategically located across the US, EU & Asia.
• All of our consultants have a minimum of 15 years of industry experience.
• Our senior leadership team extensively vets every consultant to ensure they provide our clients with superior support and guidance, ensuring a one-stop-shop for all their quality system, regulatory, and compliance needs.
• E.M.M.A. International Consultants are innovative and focused on addressing your needs.
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Services and Solutions
Audits Certifications
Customer Complaint Handling
CAPA
Design Control
Remediation Support
Supplier Quality Training
Lean Six Sigma
Deployment
Quality System
Development
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Industries Served
Medical Devices Chemicals Food and
Beverage Healthcare
Laboratories Automotive Pharmaceuticals Biotechnology
Biologics Blood and Tissue
Contract Manufacturing Tobacco
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FDA Compliance• We offer a wide variety of FDA compliance services and
solutions to all types of businesses and organizations that are regulated by the FDA in the United States and internationally.
• E.M.M.A. International Consulting Group, Inc. is considered a leading consulting firm for all FDA regulatory matters.
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Our primary consulting services for FDA compliance
• 483 responses• Warning Letter responses • Remediation strategies• Labeling and website reviews• Audits and gap analyses• Mock FDA inspections• Regulatory submissions
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Quality SystemsOur primary consulting services for Quality Systems include:
•Corrective and Preventive Action (CAPA) process• Problem Solving•Manufacturing QA/QC•Validation
•Quality Audit•Customer Complaint Handling•Design Controls• Supplier Quality
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ISO Standards
Our primary consulting services for ISO Standards focus on the following standards:
ISO Standard
s
ISO 9001
ISO 1348
5
ISO 1497
1
ISO 1400
1
ISO/TS
16949
ISO 1518
9
ISO 2200
0
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Regulatory AffairsOur primary consulting services for Regulatory Affairs include:
• Certifications• ISO certifications • Market devices overseas• Submissions for CE certification
and product CE marking• JPAL (Japan) and CMDI (China)
registration• Clinical Trials• Oversee clinical trials and assure
compliance with GCP regulations
• Submissions & Filings• Preparing your NDA, PMA, 510(k) and other FDA submissions
• Recalls• Outsource your recall process
• Compliance Issues • FDA 483 reports • Warning Letters • Consent Decrees • ISO audits
• Customer audits
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Outsourced Quality Assurance (OQA) Program
• Let E.M.M.A. International oversee your Quality Management System (QMS) and function as your QA/RA organization• Ensure you are on track to obtain and/or maintain
certifications• Outsource specific functions such as supplier quality or
internal audit • Outsource your regulatory affairs activities and
submissions• Reduce your overhead cost and expenses
Outsource all, or part, of your Quality Assurance Department to E.M.M.A. International using our Outsourced Quality Assurance (OQA)
Program
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Testimonials"Our engagement of Carmine Jabri of E.M.M.A. International Consulting Group was a pleasant
departure from my experience of a typical consulting relationship. Carmine and I worked together
to set the goals, timetable and budget for the project early on. He kept me apprised of our
progress on a regular basis and there were no surprises. We accomplished our goals on time and
on budget.
Carmine was able to adapt his style and content to match our industry, personnel and culture. He
remained positive and supportive throughout and was never judgmental or condescending to me or
any of my people. I would recommend Carmine to any leader who feels like I did, overwhelmed by
the complex quality demands of today’s customers and regulators.”Mark DroletPresident, Premiere Packaging Inc.
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Testimonials"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. When we fell down on resources E.M.M.A. International brought in the necessary subject matter experts to keep the plan on track and train our personnel. During the process we encountered many issues unrelated to the new QMS effort and your team jumped in and not only assisted, but helped us develop a strategy to remediate every issue. We also took advantage of their Outsourced Quality Assurance (OQA) program. I recommend any company with QMS needs to take advantage of E.M.M.A.’s OQA program.
There is not enough space here to share all the benefits of using E.M.M.A. International. Please feel free to share this correspondence and give my contact information to any interested parties. I would like to share the success we have achieved thanks to the knowledge and experience of E.M.M.A. International."
Thomas Baughman, CEONew Concept Technology, Inc.
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Why Choose E.M.M.A. International• We do not merely render advice, outsource our talent, or provide
“cookie cutter” solutions, as many consulting firms tend to practice. • We do not “leave you hanging” with a process or system that is
foreign to your organization and ultimately becomes unworkable. • Our mission is to provide significant value to your operations and
leave you completely satisfied that your expectations were fulfilled. • We work within your corporate culture and alongside your
employees to do the “heavy lifting” required to make improvements meaningful and permanent.
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Contact Us
27600 Farmington Rd., Suite 100 Farmington Hills, MI 48334
248-987-4497