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


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


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

http://www.emmainternational.com/about/our-team.html


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.


Services and Solutions

Audits Certifications

Customer Complaint Handling

CAPA

Design Control

Remediation Support

Supplier Quality Training

Lean Six Sigma

Deployment

Quality System

Development


Industries Served

Medical Devices Chemicals Food and

Beverage Healthcare

Laboratories Automotive Pharmaceuticals Biotechnology

Biologics Blood and Tissue

Contract Manufacturing Tobacco


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.


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


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


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


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


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


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.


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.


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.


Contact Us

27600 Farmington Rd., Suite 100 Farmington Hills, MI 48334

248-987-4497

https://twitter.com/EMMAIntl

https://www.linkedin.com/company/emma-international-consulting-group?trk=nav_account_sub_nav_company_admin

http://www.emmainternational.com/

e.m.m.a. international company overview

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