Meet the seasoned leaders behind TQC – a consortium of global experts in quality, regulatory, and safety, united by a mission to deliver smarter, real-world solutions across the life sciences industry.
Quality Assurance SME
Phone Number: (234) 109-6666
Email Address: sdukamp@thequalitconsortium.ca
Stuart is the President and Founder of The Quality Consortium and has over 35 years of experience in the pharmaceutical industry, including 10 years as an analytical chemist (formulation development / clinical trial manufacturing), 25 years within Quality Management, and 12 years within CMO organizations.
Stuart has established a reputation as a dynamic quality leader with a demonstrated history of driving companies to success, especially during periods of notable change. He is a seasoned Quality Auditor with global experience of auditing pharmaceutical, API, sterile, biotechnology, OTC, and cosmetic manufacturing facilities, specifically within North America, Europe, India, and China.
Stuart is a systems builder with a reputation for bringing transformational change to organizations. He is also an ‘ideas’ guy and innovator who thrives in environments that demand pragmatic, cost effective and timely solutions to complex problems.
Stuart holds a bachelor’s degree in chemistry and Analytical Science from Loughborough University, UK, and certified, as both a Chartered Chemist (UK) and a Professional Chemist (Canada). Stuart’s previous companies include SmithKline Beecham, Raylo Chemicals, QSV Biologics, Septodont, TPIreg, and Innomar Strategies (Cencora).
Raje is a certified Regulatory Affairs and Quality Assurance professional with over 20 years of global experience focused on medical devices and Biologics drugs, including in vitro diagnostics (IVD), combination products, clinical delivery systems, robotics, implantables, ophthalmic devices, AI/ML-driven SaMD, and digital health technologies. She is adept at leading complex regulatory strategies and quality system implementations across FDA, Health Canada, EU MDR/IVDR, TGA, and APAC markets.
She brings deep expertise in device lifecycle management, from concept and design control to market access and post-market surveillance. She has driven 510(k), De Novo, PMA, CE marking, IVDR, and Health Canada submissions, and supported design dossiers, technical files, and risk-based regulatory pathways for Class I–III devices. Her work spans both standalone and combination products, including autoinjectors, neuro implants, infusion pumps, surgical instruments, and IVD assay platforms.
Raje has implemented and audited QMS aligned with ISO 13485, 21 CFR Part 820, MDSAP, and ISO 14971, covering CAPA, supplier controls, usability (IEC 62366), and software lifecycle (IEC 62304). Raje can also support clients with FDA pre-submissions, ACNU filings, and clinical investigations under GCP, ISO 14155, and PMS/PMCF frameworks.
She also brings deep expertise in U.S. drugs regulatory pathways, including Biologics License Applications (BLA), Investigational New Drug (IND) submissions, New Drug Applications (NDA), and Abbreviated NDAs (ANDA), supporting both originator biologics and biosimilars.
Raje also offers hands-on support in technical documentation, regulatory gap assessments, real-world evidence studies, and digital health policy navigation.
Dr. Benjamin brings unmatched depth and clarity to the table with 20+ years in consulting, pharmaceutical compliance, senior leadership roles at GSK and Cencora, and a reputation for excellence in leading global GVP / GCP audits and audit readiness strategies. He is also a recognized voice in the responsible use of AI in drug safety, helping organizations operationalize ethical innovation in regulated environments.
He holds a Doctorate in Business Administration (DBA) from the US, focusing on healthcare leadership, an MSc. in International Business from the UK, focusing on Operational Excellence in health systems, and a BSc. in Biology/Chemistry. Dr. Benjamin is also a certified Lean Six Sigma Master Black Belt, reinforcing our global cross-disciplinary approach to solving complex regulatory challenges.