EMMA International is a leading FDA compliance consulting firm. We provide cost-effective solutions for FDA regulatory affairs, compliance services, quality systems, remediation, regulatory filings and submissions. Our expertise includes medical devices, biotechnology and pharmaceutical industries.
EMMA International always prioritizes their clients’ needs and believes that their clients’ success is the firm’s success.
A Holistic Approach
EMMA International always takes a holistic approach to engagements with a strong emphasis on their FDA expertise. Beyond solving the immediate short-term challenges, we consider other hidden or future issues.
EMMA International’s in-house team fully integrates with the client’s stakeholders ensuring a close partnership and seamless management of the client’s most complex challenges.
One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...
Across all industries, documentation is a key aspect of maintaining good quality and traceability over products. Therefore, having good documentation practices (GDP) is an essential tool and something that requires repetitive training to ensure proficiency. Especially in the life science industries, having good documentation improves overall product quality and allows for clearer traceability and validation within processes. GDP practices can be done using the acronym, ALCOA, which stands for Attributable, Legible, Contemporaneous, Original, and Accurate.
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.
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
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.
Director of Corporate Advancement,
Our engagement 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.
Premiere Packaging Inc.
Carmine is one of the best in the Industry for Quality and Compliance in the Medical field. He is extremely knowledgeable with Quality and FDA procedures and has successfully implemented projects helping businesses with their challenges and pain points. I am highly impressed with his operational skills and his ability to integrate quality standards with improved methodology and efficiencies.
Yoel Yohan Partner
Author of "The Corporate Drain",
The Progress Group