Jay Prabaharan, Quality Consultant
BSc, MSc, Dip Edu, MRSC, IRCA Registered PQMS GMP Auditor Membership No:6107760
Chief Executive Officer and Founder of Medicpharma Consultance Ltd, Jayagowriy Prabaharan bringing over two decades of experience in pharmaceutical, medical devices and Software implementation. An expert in ISO 9001 and ISO13485 and an academic trainer in driving compliance, innovation and risk-based quality strategies. Jayagowriy is an accomplished and highly performing pharmaceutical scientist with extensive quality assurance, quality control, data analytics, analytical validation, QMS, and auditing experience.
Biopharmaceutical Senior Consultant
Senior Consultant
The Biopharmaceutical Senior Consultant at Medicpharma Ltd brings over 15 years of experience in biopharmaceutical research, clinical development, and regulatory compliance. They have led clinical program design, technology transfer, and global regulatory submissions for drug, device, and diagnostic products. Their expertise spans GCP, GMP, and GxP frameworks, as well as clinical performance evaluation under IVDR, MDR, and FDA regulations. Combining scientific insight with strategic oversight, they help clients accelerate safe, compliant, and effective biopharmaceutical innovations across international healthcare markets.
UK Regulatory & Quality Consultant
Senior Consultant
The Medical Devices Senior Consultant at Medicpharma Ltd, bringing over 15 years of experience in medical device design, research, regulatory affairs, and quality management. A certified ISO 13485 Internal Auditor, he has led global CE marking, risk management (ISO 14971), and biocompatibility (ISO 10993-1) programs. Dr. Prabaharan has collaborated with leading Notified Bodies including TÜV SÜD, KIWA, BSI, and LRQA, and is known for bridging technical innovation with regulatory excellence, ensuring products reach the market safely, effectively, and in full compliance US Regulatory & Quality Consultant
US Regulatory & Quality Consultant
Senior Consultant
The US Regulatory & Quality Consultant at Medicpharma Ltd brings over 25 years of global leadership in medical devices, diagnostics, and life sciences. An expert in FDA, EU MDR/IVDR, and MDSAP frameworks, they have led 510(k), PMA, IDE, and Breakthrough Device submissions and global QMS harmonization projects. A Six Sigma Black Belt and Certified Biomedical Auditor, they specialize in SaMD, AI/ML technologies, and risk-based regulatory strategies, helping clients achieve faster approvals, compliance excellence, and sustainable market access across the US, EU, and international markets.
US Quality Systems & Data Analytics Consultant
Senior Consultant
The US Quality Systems & Data Analytics Consultant at Medicpharma Ltd brings over 15 years of experience in laboratory quality management, ISO 17025 accreditation, and lean process optimization. With a PhD in Biotechnology and a postdoctoral fellowship in Radiation Medicine, they have led successful QMS implementations, internal audits, and continuous improvement programs across testing and technical service environments. An expert in data analytics, Power BI, and process automation, they integrate scientific, regulatory, and operational excellence to deliver robust, compliant, and data-driven quality systems for global clients.
EU Regulatory & Quality Consultant
Senior Consultant
The EU Regulatory & Quality Consultant at Medicpharma Ltd brings over 15 years of international experience in in vitro diagnostics (IVD), medical devices, and pharmaceuticals. Formerly a Lead Auditor and Product Specialist with TÜV SÜD, they have led IVDR, MDSAP, and ISO 13485 implementations and audits across Europe and global markets. With expertise in regulatory strategy, digital QMS transformation, and technical documentation, they have guided large-scale IVDR product classifications and EUDAMED registrations. A Six Sigma Black Belt and certified Lead Auditor, they ensure clients achieve compliance, efficiency, and sustainable regulatory excellence.