A Global Leader in FDA Consulting Services
New horizons are discovered every day as technology is advancing at a rapid rate especially in the Biotechnology, Pharmaceuticals, and Medical Device industries. These domains are leading with cutting-edge technology solutions. The driving force behind such magnificent feats is the need of the hour. With new technologies such as Artificial Intelligence (AI) and Machine Learning (ML) making big waves in a lot of industries, Medical Devices are also leveraging the use of these sophisticated technologies.
By supporting the implementation of these technologies, EMMA International is paving the way for several businesses to become more productive and efficient. The firm is a global leader in FDA consulting services with an exclusive focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device Industries. It provides services that address every quality and compliance need backed by extensive knowledge and industry experience.
EMMA International understands that the life sciences industry is making headways toward innovative technologies like 3D printing. Thanks to advancing science, what once seemed like science fiction is now becoming reality for the medical device industry. Through their involvement with national organizations, EMMA International is deeply involved with the continuous improvement of the medical device industry and is also on the forefront of the ever-changing regulatory landscape.
A Symbol of Excellence
EMMA International is headquartered in Bingham Farms, MI. From there, the firm provides a wide array of specialized quality, regulatory, and compliance services for companies in the Life Sciences industry across the US and the globe. Through an infrastructure that includes a proprietary methodology, unparalleled expertise and extremely competitive pricing models, the firm focuses on innovation to address client needs by providing cutting-edge solutions to common problems. Instead of implementing complex solutions in the clients’ processes, EMMA International goes that extra mile to ensure that it has delivered significant value to clients’ systems.
EMMA International works alongside clients’ teams to implement improvements and hence, bring more value to its services. The firm is on a mission to provide meaningful and permanent solutions that would exceed all expectations.
EMMA International is certified as a Women’s Business Enterprise (WBE) through the Women’s Business Enterprise National Council (WBENC). It is also ISO 9001:2015 certified for its quality management system. Apart from EMMA International’s wide reach and capability in FDA compliance, the company’s core competency lies in its ability to develop and implement integrated Quality Management Systems (QMS) that conform to a multitude of international regulatory requirements and/or ISO standards. As FDA regulations become more stringent, EMMA International strives to serve companies across the globe by helping them develop an individualized plan to mitigate major challenges in implementing QMS processes.
An Edge over Competition
EMMA International is comprised of a technical team, operations team, and a business development team that work around the clock to push the boundaries and deliver unparalleled services. Every team member has abundant professional experience in the regulated industries, and the expertise the entire EMMA team brings to the table is unmatched. The EMMA International team’s diverse knowledge and specialization help the company undertake challenging tasks and complex projects.
Along with an expert team, EMMA International deploys unique strategies that give it an edge over its competitors. Strategies the company employs include:
- Expertise: EMMA International’s multinational experience combines industry-leading methodology, internal leadership, personnel support, and scalable consultant partnerships to optimize process knowledge for clients
- Speed: Utilizing a hybrid model of internal personnel and consultant partnerships, EMMA International’s deployment speed and scalability are unparalleled, with emergency sourcing within 24 hours and scalability examples of 20 resources within 5 business days.
- Delivery: EMMA International’s practice-focused leadership, coupled with client leadership drive employee performance and project execution, making sure your timelines are met.
- Flexibility: With industry-leading internal experts’ utilization, EMMA International provides an optimal approach for insourcing and outsourcing, with the deployment power for onsite turn-key teams and internal support for specialized, short-term project needs.
- Retention: EMMA International operates with an 80% internal expert utilization, meaning 80% of the deployed teams work directly for EMMA International rather than contract through EMMA International. Compared to industry competition rates of 5-10%, EMMA International can provide the highest level of resource consistency for your project.
Additionally, EMMA International recognizes the commitment to supplier diversity that is embraced by corporations and government agencies today, and as a certified Women’s Business Enterprise (WBE), the company can add diversity to clients’ supply chain.
Driving the Unparalleled Success
At the helm of EMMA International is Dr. Carmine Jabri – Co-founder & President of the company. He is an experienced Healthcare and Quality Assurance professional with more than two decades of experience. From directing to implementing and improving quality management systems and healthcare operations, Dr. Jabri has successfully led a variety of operations in the life-sciences space. Dr. Jabri is an internationally sought-after quality systems expert whose career includes expertise in the Pharmaceuticals and Medical Device industries.
Dr. Jabri’s extensive knowledge of FDA regulations and guidelines, coupled with his training and facilitation skills, help him lead the EMMA International team to help organizations improve their quality management systems, reduce costs, reduce errors, and comply with federal, state, and international standards and regulations.
Shaping the Journey
Throughout his career, Dr. Jabri identified the need within the FDA regulated industries for senior-level subject matter expertise in the quality and regulatory arenas to guide organizations through the complex regulatory landscape.
EMMA International was founded in 2013 to carry out this vision. As the firm grew, Dr. Jabri and his team adapted to the evolving needs of their clients and expanded their services to offer a boutique of unique solutions that can help companies navigate the complex regulatory channels, and provide additional support to ensure FDA compliance. Headquartered in Metro Detroit, family-owned, and serving the globe, EMMA International is a well-known global leader in FDA consulting services.
EMMA International is poised to become an innovative pioneer in the industry in the coming years. “We want to become a think tank in the life sciences’ innovative technology space, and further nurture our strategic partnerships and alliances toward shared goals. Ultimately, effecting change on a global level is a goal,” concludes Dr. Jabri.
EMMA International anticipates that Artificial Intelligence (AI) and Machine Learning (ML) will play a significant role in the Life Sciences industry. In particular, the medical device industry is on the verge of some amazing technological developments that incorporate AI and ML.
Dr. Jabri and the team have created a company that provides a true management consulting experience for the medical device industry.