Helping organizations deploy artificial intelligence safely, compliantly, and with confidence
E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in quality, regulatory, and compliance consulting for the life sciences industry, today announced the launch of its AI Solutions. This new offering is designed to help regulated organizations harness artificial intelligence while maintaining the highest standards of safety, quality, and regulatory integrity.
As artificial intelligence reshapes research, manufacturing, clinical development, and quality systems, life sciences organizations face increasing pressure to adopt AI responsibly. In highly regulated environments, AI implementation must be strategic, defensible, and aligned with evolving expectations from the FDA, EMA, and global health authorities. EMMA International’s AI Solutions address this challenge by guiding organizations through the design, validation, integration, and governance of AI-enabled systems.
“AI has enormous potential to transform the life sciences, but only when it is implemented with discipline, evidence, and oversight,” said Dr. Carmine Jabri, Chief Executive Officer of EMMA International. “Our AI Solutions help organizations innovate with confidence by ensuring their AI systems are compliant, auditable, and built for long-term success.”
EMMA International’s AI Solutions support organizations across the full AI lifecycle, from early concept and feasibility through deployment and post-market management. The firm provides regulatory strategy for AI- and machine-learning-enabled products, helping clients determine appropriate regulatory pathways, align claims with algorithm functionality, and prepare submissions consistent with FDA Good Machine Learning Practice, EU MDR/IVDR, and global guidelines.
In addition, EMMA International supports AI validation and quality system integration, addressing critical considerations such as data integrity, model performance, bias monitoring, explainability, and lifecycle controls for continuously learning algorithms. The firm also assists organizations in deploying AI-driven process optimization and intelligent automation across documentation, quality records, supplier oversight, manufacturing analytics, and clinical data review—reducing manual burden while strengthening compliance.
Recognizing that successful AI adoption requires more than technology alone, EMMA International also offers AI governance and risk management services. These include governance framework design, policy development, post-market surveillance planning, and training programs to ensure AI systems are managed responsibly throughout their lifecycle. Strategic AI road-mapping services help organizations identify high-value opportunities, assess risk, and align AI investments with business, regulatory, and quality priorities.
With cross-disciplinary expertise spanning AI, regulatory affairs, quality systems, and data governance, EMMA International is uniquely positioned to support AI adoption in regulated environments. The firm works with pharmaceutical, biotechnology, medical device, diagnostics, and digital health organizations to deploy AI solutions that accelerate innovation without compromising compliance.
For more information about EMMA International’s AI Solutions, visit https://emmainternational.com/ai-oriented-services/ or contact Shelby Whitelaw, Marketing Specialist, at (248) 987-4497 or shelby.whitelaw@emmainternational.com.
