Our Team
Experienced. Multidisciplinary. Global.
Our team comprises seasoned professionals with hands-on expertise in pharmaceutical and biotechnology dosage forms, including solid, semi-solid, and liquid formulations — across both sterile and non-sterile platforms. From early development to commercial manufacturing, our experts bring in-depth understanding and practical experience across diverse product categories and regulatory landscapes.
We are proud to bring together:
Quality Experts – Specializing in cost-effective quality solutions, data integrity compliance, and remediation strategies aligned with global standards continuous improvement across sterile and non-sterile operations.
Operational Experts – Driving efficiency in manufacturing, technology transfer, and batch execution with deep process knowledge.
Engineering Experts – Designing, qualifying, and maintaining GMP-compliant equipment and facilities that support various dosage forms.
Regulatory Affairs Experts – Guiding global product registration, dossier preparation (CTD/eCTD), and audit readiness.
IT and Security Experts – Supporting data integrity, electronic systems validation (CSV), and pharma-grade cybersecurity.
Project Management Experts – Leading end-to-end execution of strategic initiatives with cross-functional coordination.
Analytical Experts (QC & Microbiology) – Delivering accurate and compliant testing for raw materials, finished products, and environmental controls.
Business Development and Marketing Experts – Strategically expanding market presence, identifying growth opportunities, and building strong client relationships.
With a multidisciplinary approach and deep domain knowledge, our team enables clients to navigate complex challenges, achieve regulatory compliance, and drive innovation in the life sciences sector.
Ashok Baban Satpute
Pharmaceutical Operations & Manufacturing Expert with 31+ Years of Pharmaceutical Industry Experience
Key Expertise:
Plant Operations • Pharmaceutical Manufacturing • GMP/cGMP • Technology Transfer • Process Optimization • Qualification & Validation • Regulatory Audits • Greenfield Projects • Manufacturing Excellence
Ashok is a seasoned pharmaceutical professional with over 31 years of experience in pharmaceutical manufacturing, operations management, quality systems, and manufacturing excellence. His expertise covers a wide range of pharmaceutical dosage forms, including sterile and injectable products, lyophilized products, biological and blood products, ophthalmics, tablets, capsules, liquid orals, external preparations, and TDDS.
He has held senior leadership positions with responsibility for end-to-end plant operations, production, quality, maintenance, supply chain, projects, and workforce management. His experience includes GMP/cGMP compliance, technology transfer, process optimization, qualification and validation, regulatory inspection readiness, greenfield projects, and manufacturing excellence.
Ashok has extensive experience with regulated markets and international regulatory/customer audits, including exposure to USFDA, MHRA, WHO, TGA, and other regulatory and customer requirements.
His practical manufacturing leadership and operational expertise enable JivRx to support clients in building compliant, efficient, quality-focused, and sustainable pharmaceutical manufacturing operations.
Rajesh Krishna Yadav
Pharmaceutical Quality & Regulatory Expert with 24+ Years of Pharmaceutical Industry Experience
Key Expertise:
Quality Assurance • Quality Control • GMP/GLP • Data Integrity • Data Governance • CSV • Investigations • CAPA • Risk Management • Regulatory Audits • Quality Systems
Rajesh is an accomplished pharmaceutical quality professional with more than 24 years of experience across Quality Assurance, Quality Control, Analytical Development, regulatory compliance, quality management, and audit management. His expertise includes cGMP, cGLP, data integrity, data governance, computer system validation, quality investigations, risk management, CAPA, and quality-system improvement.
He has extensive hands-on experience in managing OOS, OOT, deviations, change controls, market complaints, audit observations, investigations, and CAPA, with a strong focus on sustainable quality-system improvement.
Rajesh has participated in regulatory and customer audits involving USFDA, EDQM, TGA, MHRA, WHO, and other organizations. His experience includes participation in 200+ national and international customer audits and conducting 100+ external audits covering APIs, intermediates, formulations, raw materials, warehouses, analytical laboratories, and R&D facilities.
His combination of quality-system expertise, regulatory knowledge, and extensive audit experience enables JivRx to support organizations in strengthening GMP compliance, improving audit readiness, enhancing quality systems, managing data integrity, and driving continual improvement.