Chuck H. Mograbi, M.S. (Hons), PMP

Founder & Principal Scientific Consultant

Charles "Chuck" Mograbi Founder, President & Executive Regulatory Intelligence Leader Charles "Chuck" Mograbi is the Founder and President of Natissmo Inc., bringing more than 20 years of executive leadership across regulatory affairs, engineering, quality systems, clinical development, validation, software, artificial intelligence, and global product commercialization within the life sciences industry. Throughout his career, Chuck has successfully led multidisciplinary programs supporting medical devices, in vitro diagnostics (IVD), cardiovascular technologies, ophthalmic systems, robotic-assisted platforms, software-enabled and AI-enabled medical technologies, pharmaceuticals, biologics, food, cosmetics, and combination products. His expertise lies in integrating engineering, regulatory affairs, clinical strategy, quality systems, manufacturing, software development, cybersecurity, validation, and executive leadership into successful global product development and commercialization programs. Chuck has directed regulatory strategies supporting FDA 510(k), PMA, De Novo, eSTAR, IDE, IND, NDA, BLA, EU MDR Technical Documentation, CE Marking, Health Canada, PMDA, NMPA, and other international regulatory pathways, while collaborating with Fortune 500 companies, innovative startups, research institutions, and global healthcare organizations. Today, Chuck is leading the development of Natissmo Regulatory Intelligence™, a next-generation platform designed to integrate Artificial Intelligence with scientific, engineering, clinical, regulatory, and quality expertise to help organizations make better regulatory decisions, accelerate product development, and improve global compliance. Executive Leadership Highlights Integrated Regulatory Leadership Successfully integrates engineering, regulatory affairs, clinical development, quality systems, manufacturing, validation, software development, cybersecurity, and executive leadership to deliver complex multidisciplinary programs from concept through global commercialization. FDA & Global Regulatory Strategy Extensive experience leading FDA 510(k), PMA, De Novo, eSTAR, IDE, IND, NDA, BLA, EU MDR Technical Documentation, CE Marking, Health Canada, Japan, China, Brazil, APAC, LATAM, and other international regulatory pathways. Scientific & Engineering Expertise Supports complex technologies including medical devices, pharmaceuticals, biologics, IVD, ophthalmic systems, cardiovascular products, robotic-assisted surgery, software as a medical device (SaMD), AI-enabled technologies, food, cosmetics, and combination products. Quality & Compliance Excellence Expert in FDA remediation, CAPA, ISO 13485, Design Controls, Risk Management (ISO 14971), Human Factors, Cybersecurity, Verification & Validation, IQ/OQ/PQ, Computer System Validation, and global quality systems. Regulatory Intelligence Vision Founder of Natissmo's vision to transform traditional regulatory consulting into Integrated Regulatory Intelligence, combining Artificial Intelligence with decades of multidisciplinary scientific and engineering expertise to support faster, more informed, and globally compliant regulatory decision-making.

Rasha Khatib

Senior Analytical Chemistry & Regulatory Compliance Consultant

Analytical chemistry and laboratory operations professional with over 17 years of multidisciplinary experience supporting FDA-regulated pharmaceutical, cosmetic, medical device, laboratory, and healthcare operational environments.

Mark Daniel Proulx

Senior Quality, Regulatory & Operational Excellence Consultant

Senior quality, remediation, operational excellence, and regulatory compliance consultant with extensive experience supporting FDA-regulated medical device, pharmaceutical, biotechnology, ID, and combination product organizations involving remediation strategy, MD transition activities, quality systems, CAPA, validation, and operational transformation initiatives.

Nahu Alula

Cybersecurity & Network Security Consultant

Cybersecurity and network security consultant focused on protecting systems, infrastructure, and data.