Rajesh Pai is a Senior Pharmaceutical Consultant based in South Africa, with over 25 years of experience in both sterile (SVPs—ampoules, vials, cartridges, ophthalmic, LVPs) and non-sterile (tablets, capsules, softgels, liquids, creams, ointments) dosage forms. His expertise extends to specialized areas such as cytotoxic, beta-lactam, cephalosporin, radiopharmaceuticals, complementary medicines, and cannabis-based pharmaceutical products.
Rajesh is a proud alumnus of the 1997 batch of Manipal College of Pharmaceutical Sciences (MCOPS), India. He is a member of ISPE and PDA, which helps keep him up to date with global best practices while providing pragmatic, real-world solutions to GMP requirements. Rajesh regularly delivers training on key cGMP topics, including Pharmaceutical Quality Systems (PQS), Contamination Control Strategy (CCS), Data Integrity Risk Assessment (DIRA), Commissioning & Qualification (C&Q), and Validation.
He has played a pivotal role in gap assessments, remediation, skill development, facility layout design, setup, and technology transfer for numerous greenfield pharmaceutical manufacturing projects, ensuring alignment with international regulatory expectations such as ANVISA, Health Canada, MHRA, SAHPRA, USFDA, and WHO.
Alongside his consultancy, Rajesh lectures postgraduate students on Pharmaceutical Production (cGMP) at the University of the Witwatersrand (WITS), South Africa, and serves as an Honorary Advisory Board Member at the Centre for cGMP, MAHE, Manipal, India.
He has been a featured speaker on pharmaceutical operations and quality management at respected platforms, including the ISPE Pharma Best Practices Webinar Series, the Cleanroom Forum (South Africa), and ZAZIBONA–cGMP Quality Circle.
Rajesh Pai’s Core Competencies are
Mr Mahesh Rao is a seasoned Quality professional with excellent academic credentials and carries rich experience in the pharmaceutical industry. Mr Rao is currently working as Chief Quality Officer with Integrated Biopharma and Pharma Solutions (IBPS) & also serves as an Honorary Advisory Board Member at the Centre for cGMP, MAHE, Manipal, India. Mr Rao was involved in the Vaccine project - " Mission COVID Suraksha" with BIRAC and Department of Biotechnology (DBT), responsible for the review of facility and equipment design and qualification, quality systems, personnel planning and training. Prior to joining IBPS, his last assignment was with Cipla Ltd at the capacity of Director – Head, Site Quality Assurance at Indore.
Mr Rao has served in pharmaceutical companies of high repute namely, Cipla Biotec Pvt Ltd, Onco Therapies Ltd, Aurobindo Pharma, Lupin Ltd and Indoco Remedies Ltd. Mr Rao carries 24+ years of extensive experience in sterile injectables and other dosage forms in Manufacturing, Quality Management Systems and Investigations. He led site and unit teams in multiple regulatory inspections successfully, including USFDA, EMA, TGA, WHO, ANVISA inspections.
Kirankumar Hunashimarad is the Vice President of Corporate Development at Ingenus Pharmaceuticals LLC, where he leads strategic initiatives across business development, in-licensing and out-licensing, portfolio management, and commercial launches. With deep expertise in Research & Development, Project Management, and Strategic Planning, Kirankumar drives growth opportunities and partnerships that expand Ingenus’s footprint in the global pharmaceutical market. He also serves as an Honorary Advisory Board Member at the Centre for cGMP, MAHE, Manipal, India.
Throughout his career, he has successfully overseen complex projects from concept to market, leveraging his scientific insight and business acumen to deliver sustainable value. His collaborative leadership style and results-driven approach have contributed to multipleproduct launches and strategic deals.
He is dedicated to advancing innovation by contributing his knowledge and expertise to society, working to make impactful healthcare solutions more widely accessible.
Mrs. Akshaya Bhandarkar is currently serving as a faculty member in the Department of Pharmaceutics at Vidya Siri College of Pharmacy, Bangalore. She brings with her over 12 years of professional experience, including 3 years in academia and 9 years in the pharmaceutical industry. Her industry tenure includes prominent roles in leading pharmaceutical companies such as Sanofi (Brazil) and Mylan Laboratories Ltd., where she served as a Quality Assurance Specialist. Additionally, she has worked as a Formulation Scientist at Micro Labs Ltd. and FDC Ltd., contributing to the development of a wide range of pharmaceutical dosage forms. She holds specialized expertise in sterile dosage forms and has been actively involved in formulation development and regulatory compliance in both domestic and international markets.
Mrs. Bhandarkar completed her Bachelor’s NGSM Institute of Pharmaceutical Sciences, Mangalore under Rajiv Gandhi University of Health Sciences, Bangalore and Master’s from Nitte University, Mangalore.
In addition to her academic and industrial experience, Mrs. Bhandarkar serves as the Co-Editor of the KRPA Monthly Bulletin, published by the Karnataka Registered Pharmacists Association. In this role, she is actively involved in reviewing articles curated by students related to advancements in pharmaceutical sciences. Her editorial contributions aim to enhance knowledge sharing and engagement within the pharmacy community.
Mrs. Bhandarkar has also contributed to content development projects with Ansrsource, a U.S.-based e-learning provider. As a GMP trainer with PharmaLiterati, a Mumbai-based e-learning platform focused on pharmaceutical education, Mrs. Bhandarkar contributes to their Pharmacy Practice Program for final-year B.Pharmacy students. She delivers training sessions on the fundamentals and importance of Good Manufacturing Practices (GMP), highlighting their role in ensuring product quality, regulatory compliance, and patient safety. Her sessions also address the serious repercussions companies may face in the event of GMP non-compliance.
Ms. Jyotsna Agnihotry is currently serving as the Head of Quality Assurance & Regulatory Affairs at a European pharmaceutical company in Germany, this globally recognized pharma leader brings over 15 years of strategic experience in regulatory affairs, GMP/GDP compliance, and quality systems related to both active pharmaceutical ingredients (APIs) and finished dosage forms. With a career spanning operation across Europe, North America, India, and China, they have served as the key liaison for inspections, submissions, and regulatory strategy with agencies including the FDA, EMA, EDQM, PMDA, MHRA, WHO, and national authorities.
A highly regarded speaker and thought leader, they have been featured in CPHI Online Magazine and presented at prestigious platforms such as CPHI Worldwide (Milan), Pharma Congress Europe (2024, 2025), Pharma TRACKTS! Berlin, and the Global Regulatory Strategy Summit in Tokyo. They have also contributed to mentoring programs through CPHI, served as a certified trainer under the Life Sciences Sector Skill Development Council (LSSSDC), and addressed academic and regulatory audiences in India and Europe, including TEDx at IIT Kanpur and the Europe Qualified Person Forum in the Netherlands.
As an active member of RAPS, ECA, and the International Pharmaceutical Federation (FIP), their contributions are widely recognized across the global quality and regulatory community. Their expertise includes inspection readiness, supplier qualification across continents, strategic submissions (CEPs, ASMFs, DMFs, eCTD dossiers), and Qualified Person (QP) support for EU batch release. They are also the single point of contact for global Lean Six Sigma projects and hold authorizations aligned with §§13, 52a, and 72 AMG.
Holding an M. Pharm in Drug Regulatory Affairs, an MBA in Business and Corporate Law, and a B. Pharm from Manipal University, they are currently research scholars at Jaipur National University. Professionally certified in ISO 9001:2015, Lean Six Sigma (Green Belt), GAMP 5, FMEA, and Data Integrity, they have also completed FDA’s CDER Learn training on human drug regulation. Their achievements have been recognized with numerous accolades, including “Employee of the Year” and two Chairman Excellence “WOCK STAR” Awards, underscoring their lasting impact on pharmaceutical quality leadership worldwide.
To elevate the Centre for cGMP at Manipal by aligning academic excellence with real-world global regulatory standards. Committed to bridging science, compliance, and strategy through mentorship, curriculum input, and live industrial case studies for next-generation pharmaceutical leaders.
Mr. Madhav Jain is a healthcare professional currently residing in New Hampshire, USA. He finished his bachelors in Pharmaceutical Sciences from Manipal University, MCOPS and later went to Boston, in order to pursue his Masters in Regulatory Affairs in Drugs, Biologics and Medical Devices from Northeastern University. While working in a pharmaceutical industry in Massachusetts, Madhav also pursued his second Masters in Project Management from Harrisburg University, Pennsylvania. He worked in a contract manufacturing organization based in Boston, MA as a Quality Assurance Associate, and in 2 years, made his way up to Quality Assurance Team Lead, where he was responsible to lead a team of Junior and Senior Quality specialists, train them and manage quality of commercial and clinical scale projects drugs manufacturing.
While working in Boston, Madhav worked on a Lean Six Sigma Green Belt Project in collaboration with Process Insight Consulting based in UK, to reduce the number of lab/human/machine errors on Quality control data and testing, to deliver output right first time from QC labs. This project not only certified Madhav as a Green Belt professional, but also reduced lab errors to 80%. Later on, Madhav also received his Lean Six Sigma White belt certification during his second Masters and also completed a Global Business certification course from Harvard Business School Online, in order to get an understanding of global business operations.
Currently Madhav is working in an established Pharmaceutical company as a Project Manager, based in Massachusetts. He manages and leads a team of experts working on commercial products manufacturing and also clinical projects which are at various stages of clinical trials across the globe. In 2024, Madhav joined Manipal cGMP Museum as an advisory board member and has been sharing his expertise at various formats for the museum. Madhav is anextremely passionate and self-motivated professional to provide best quality healthcare and services to patients, and like to promote education and training for aspiring students in the healthcare sector.
Dr. Girish Pai K. is currently working as Associate Professor in the Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences (MCOPS), Manipal Academy of Higher Education (MAHE), Manipal, an Institution of Eminence. He has 15 plus years of teaching experience in Academia & 10 years of Professional experience in leading pharmaceutical industries handling Quality Assurance, Formulation development & Manufacturing operations (conventional & specialty / proprietary dosage forms) pertaining to various pharmaceutical products specialized in dry powder injectables.
Dr. Pai completed his Bachelor’s, Master’s & Ph.D studies in Pharmaceutical Sciences from MCOPS, MAHE. Prior to joining MCOPS in 2010, he has worked for AstraZeneca Pharma (India), Orchid Healthcare(India), Neopharma LLC (Abu Dhabi, UAE) and CFL Pharmaceuticals Ltd (India).
Dr. Pai has presented 30 research papers in reputed International & National conferences, attended 22 workshops, and authored 95 research publications in peer-reviewed international journals. Dr Pai is the editor of illustrious book, “Pharmaceutical Consumer Complaints: A guide to Academia and Pharmaceutical Industry”. Dr Pai is the recipient of prestigious Dr TMA PAI GOLD MEDAL for outstanding research in the year 2018. He has also received a few awards for research publications and in conferences for scientific poster & oral presentations.
Dr. Pai was responsible for collaborating with India’s first digital healthcare exchange company, Nerve24 Technologies Private Ltd, Mumbai. Dr Pai is also serving as Visiting Professor at Pharma Training Institute, Bengaluru which is under the aegis of Karnataka Pharmaceutical Trust. Dr. Pai is the Coordinator for the Centre for current Good Manufacturing Practices at MAHE & Corporate Relations (MCOPS). Dr Pai has organized few National workshops and International conferences on current Good Manufacturing Practices, Compliance and Data integrity
Dr. Pai was responsible for implementation of GMP systems, handling Quality Assurance, Audits & Compliance and has successfully handled International regulatory audits of agencies like USFDA, EUGMP, UKMHRA, Australian TGA, CDSCO etc. during his professional stint with pharmaceutical industries. Dr. Pai was a certified internal “Quality Auditor” in Orchid Healthcare for the conduct of internal Quality audits and Vendor audits. He has guided PG students of Sri Ramachandra University and Annamalai University while serving as Deputy Manager – Quality Assurance in Orchid Healthcare, Chennai. Dr. Pai has also received Certificate of Appreciation for his excellent contributions made in the field of Quality from pharmaceutical companies namely, Neopharma, Orchid Healthcare and AstraZeneca Pharma India Limited.
Recently, Dr Girish Pai conceived the idea of celebrating the “NATIONAL cGMP DAY” effective 10 October 2023 onwards. Dr Pai conceptualized the world’s first-ever digital museum of pharmaceutical quality, named as MANIPAL cGMP MUSEUM dedicated to Dr TMA Pai, Padmashree awardee, the founder and architect of Manipal Academy of Higher Education, Manipal. This digital museum was inaugurated on first National cGMP Day. For both these pioneering initiatives, Dr Pai received the prestigious INDIA PHARMA AWARDS 2023 and 2024 under the category of ‘Excellence in Quality’.
Dr Girish Pai Kulyadi is a faculty in the Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, MAHE, Manipal. His research interests include Formulation research, Novel drug delivery systems, Process validation, Equipment qualification, Stability studies, and GMP and Quality Assurance systems. Dr Pai has worked for AstraZeneca Pharma (India), Orchid Healthcare (India), Neopharma LLC (Abu Dhabi, UAE) and CFL Pharmaceuticals Ltd (India). Dr Pai has published more than 53 articles and research papers and also authored a book chapter. Dr Pai has successfully executed M Pharm industry collaborative projects with pharmaceutical companies of high repute, namely Lupin India Ltd, Sanofi Aventis Ltd, Dr Reddy’s Laboratories Ltd, AstraZeneca Pharma and HLL Lifecare Ltd. Dr Pai is associated as the Honorary Advisor at Nerve24 Technologies Private Ltd, Mumbai. Dr Pai has also received a few industry grants for his research proposals and is currently guiding a few PhD scholars. Dr Pai is also serving as a Visiting Professor at Pharma Training Institute, Bengaluru, which is under the aegis of Karnataka Pharmaceutical Trust. Dr Pai is also the Coordinator for Good Manufacturing Practices, Pharmaceutical Product Monitoring units at MCOPS and has successfully conducted GMP workshop in 2018. Dr Pai has received the prestigious Dr TMA PAI GOLD MEDAL for outstanding research (2017-2018) and has a few other awards to his credit. Dr Pai has delivered scientific lectures in National and International conferences.
Dr Muddukrishna BS is a faculty in the Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, MAHE, Manipal. He teaches pharmaceutical analysis to undergraduate students and pharmaceutical quality assurance and management to post graduate students of Pharmacy. He has 19+ years of total experience in academics, Research & Development, Laboratory operations & Quality Assurance in organisations of high repute. He has published several papers in journals of high repute; he has published several book chapters and has presented papers in national and international conferences. He received several awards for his research activities.
Dr Richa Ajay Dayaramani is the Principal at Kyati College of Pharmacy, Ahmedabad, Gujarat. She is Vice President of APTI Gujarat State, Member of the PG Syllabus committee at PCI, and the Founder President of Human Ethics Committees Association, working in clinical research. She has more than 19 years of experience in academic and industrial research. She is presently guiding PhD students in various challenging topics. She has published several papers in journals of high repute, has published several book chapters, and has presented papers in national and international conferences. She also has two patents to her credits.
Mr Hemanth KG, MPharm obtained his postgraduate degree from the Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, MAHE, Manipal. He completed his BPharm from Al-Ameen College of Pharmacy, Bangalore. He was an Intern in Medical Communications, Novartis HealthCare Pvt Ltd, Hyderabad, 2019, and Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), 2017. He has won several intercollege and National Level Pharmacy quiz competitions. He was a recipient of the AICTE GPAT scholarship for the year 2018-2020 and also received Tata Trusts Medical and Healthcare Scholarship for his outstanding score in First-year MPharm.
Dr Raveendra Pai is the Vice president – Formulation Development, Glenmark Pharmaceuticals R&D Ltd, Mumbai. Dr Pai has 20 years of rich experience in Pharma Industries of High repute. He has experience in product development across various dosages. He has a vast experience in meeting the requirements of global health authorities. He has successfully handled several international regulatory audits, and he has several patents to his credit. He has published several papers in journals of high repute and is a reviewer of various high-impact journals. Dr Pai was awarded with the ‘Rising Star of Year’ by the FDD conclave in the year 2018.
Mr Mahendra Joshi is the Co-founder and Director of IDRS Labs Pvt Ltd, Bengaluru. He has about 17 years of total experience in Pharma Industries of High repute. Mr Joshi has published several papers in journals of high repute and has presented papers in national and international conferences. He has several patents to his credit. He is the recipient of the BMS Crystal Award for outstanding technical leadership. He is the winner of Indian Leadership Award for Industrial Development for the year 2014, awarded by AIAF, New Delhi, India.
Dr Mahesh HRK, MSc, PhD is Vice President – Corporate Quality Assurance, Hetero Drugs Limited, Hyderabad. He has 25 years of total vast experience in Pharma Industries of High repute in the areas of Quality Assurance, Quality Control and Regulatory affairs. He is a troubleshooter for various quality issues in day to day activities. He has successfully handled several international regulatory audits. He has published several papers in journals of high repute. He has travelled to more than 25 countries and has attended various international seminars in the pursuit of quality.
Mr Ravindra Shenoy U is a faculty member at Department of Commerce, MAHE, Manipal. His research interests include ethical leadership, spirituality in leadership, Indology, Vedic management, business ethics and consumer behaviour. He has worked with corporates including the Tata Group, Gillette India and ICFAI. Mr Shenoy has published four research papers and one book chapter. Being a corporate soft skills trainer certified by TCS, he has conducted more than 45 workshops on soft skills for both students and corporate audiences. Mr Shenoy is also a member of a few prestigious international bodies including the Association of Leadership Educators, Council for Research in Values and Philosophy, Harvard Business Review Advisory Council, The Society of Corporate Compliance and Ethics, and the Advisory Committee at ISOL (Integrating Spirituality and Organizational Leadership) Asia. He is also a recipient of the Shiksha Rattan Puraskar in 2013 for academic excellence, awarded by India International Friendship Society, New Delhi.
Dr Vamshi Krishna T is a faculty member at the Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, MAHE, Manipal. His academic interests include areas of Pharmaceutics, Physical Pharmaceutics, and Pharmacokinetics, Advanced Biopharmaceutics & Pharmacokinetics, Modern Pharmaceutics, and Pharmaceutical Product Development. He has briefly worked for Advinus Therapeutics Pvt Ltd. and has spent about 12 years in academics. Dr Vamshi Krishna has published over 44 research papers and articles. He has completed his postdoctoral research fellowship on the project entitled “Confocal Raman spectroscopic analysis of cosmetic permeation through human skin” from the Laboratory of Biomedical Vibrational Spectroscopy, Universidade do Vale do Paraiba, Sao Jose Dos Campos, SP, Brazil, in July 2016. He is also a life member of the Association of Pharmaceutical Teachers of India (APTI).
Dr Girish Thunga is a faculty at the Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal. He teaches undergraduate students and post graduate students of Pharmacy. His area of academic specialisation is Drug Safety and Clinical Toxicology. He is presently guiding a few PhD students in various challenging topics. He has ten years of total experience in academics. He has published several papers in journals of high repute, several book chapters and has presented papers in national and international conferences.
