Kira Jabri, Vice President
The modern marvels of technology have enabled people to achieve cohesion in a much quicker and simpler way. For the corporate sector, compliance has been a key solution that has come as an answer to the many issues that plague large multinational establishments. Located in the evolving hub of the Motor City, E.M.M.A. International Consulting Group, Inc. has been a prime purveyor of such compliance solutions for enterprises in the United States and around the globe. The combined effort of former healthcare professionals, E.M.M.A. was originally founded with the intent to deliver quality system, regulatory, and compliance services to the Biotechnology, Pharmaceuticals, Medical Device and all other FDA regulated industries. The company has been recognized by many clients as a one-stop-shop for all their quality system, regulatory, and compliance needs and with reason. E.M.M.A.’s diverse and wide ranged service portfolio covers all possible aspects of the verticals it serves.
Most of this again comes from the vast amount of expertise being leveraged from its founders. “We provide a wide array of specialized services to our clients, backed by extensive knowledge and industry experience. E.M.M.A. International Consultants are innovative and focused on addressing your needs,” explains, Carmine Jabri, President, E.M.M.A. The implementation of Quality Management Systems (QMS), one of the company’s primary services, demands such level of experience and skills. E.M.M.A.’s delivery of this service serves the purpose of mitigating the major challenges clients face in implementing QMS in the form of cultural transformation, resource limitation and cost. E.M.M.A. addresses these issues by customizing solutions to suit the individualized needs of each customer instead of just exposing them to unfamiliar territory and just leaving them to struggle in uncharted waters.
E.M.M.A also goes the extra mile by complying with its clients’ corporate culture to make their efforts towards improvement both meaningful and permanent.
For example, for the implementation of design control processes, E.M.M.A. works with its clients’ R&D staff to develop practical and effective design requirements, validations, and Device Master Records as required by FDA. E.M.M.A. also ensures the safety and reliability of its clients’ products through the utilization of valuable tools such as FMEA and FTA. Additionally, “E.M.M.A. International Consulting Group can bring design and manufacturing risk management processes up to ISO 14971 level of compliance,” adds Kira Jabri, Vice President of the firm. More over, E.M.M.A.’s support in the attainment of ISO certifications includes, but is not limited to the following standards: ISO 9001, ISO 13485, ISO 15189, and ISO/TS 16949. The company’sexpertise with Japan’s JPAL and China’s CMDI has enabled numerous clients obtain their registration in the said markets. Further more, E.M.M.A., due to its expertise in this arena, has a proven track record of success stories in helping clients comply with many international directives including: Canadian Medical Device Regulations (CMDR), Canadian Medical Devices Conformity Assessment Scheme (CMDCAS), PMDA, ARGMD…etc.
E.M.M.A.’s diverse and wide ranged service portfolio covers all possible aspects of the verticals it serves.
Despite its wide reach and capability in compliance, E.M.M.A.’s core competence still lies in its ability to design and develop integrated Quality Management Systems. In the years to come, the company seeks to further extend its expertise in Quality System Development throughout the globe.