Dr. Ari Raju
Chief Executive Officer and Founder| Medivdpharma Consultancy Services
Dr. Ari Raju, MSc, PhD, is the Founder and CEO of Medivdpharma Consultancy Services, bringing over two decades of global experience in medical devices, IVDs, pharmaceuticals, combination products, companion diagnostics (CDx), and Software as a Medical Device (SaMD). A former Notified Body expert with TÜV SÜD, he has also collaborated with BSI, UL, LRQA, and other global authorities on regulatory and quality programs. A certified ISO 13485 and ISO 9001 Lead Auditor, Dr. Raju is also an academic trainer in European Medical Device Regulations, driving compliance, innovation, and technical excellence worldwide.
Biopharmaceutical Senior Consultant
Senior Consultant | Medivdpharma Consultancy Services
The Biopharmaceutical Senior Consultant at Medivdpharma Consultancy Services 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 | Medivdpharma Consultancy Services
The Medical Devices Senior Consultant atatMedivdpharma Consultancy Services, 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 | Medivdpharma Consultancy Services
The US Regulatory & Quality Consultant at Medivdpharma Consultancy Services 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 | Medivdpharma Consultancy Services
The US Quality Systems & Data Analytics Consultant at Medivdpharma Consultancy Services 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 | Medivdpharma Consultancy Services
The EU Regulatory & Quality Consultant at Medivdpharma Consultancy Services 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.