Leadership in
Pharmazone
Pharmazone’s steady growth is largely attributed to our humble, Self-made leadership and their strong belief in teamwork. Their innovative spirit and guidance foster a culture of mutual respect, trust, and dynamic change, all aimed at satisfying our customers’ needs.
Our organizational structure is lean and flexible, driving quick and effective decision making and thus enabling the growth of the company as well of each of our employees in the best possible way. A clear, measurable and qualified goal has been set to accomplish.
Tushar Patel
Founder & CEO
As founder and CEO, Tushar has led Pharmazone from being a small team led company to becoming the globally recognized brand among CRO industry and global generic pharmaceutical companies only in five years. Today with his clear vision and well-planned strategy, Pharmazone has expanded its operation in GMP services, Regulatory Affairs and Learning Management Services.
Our Visionaries:
People Leading Pharmazone
Dr. Ambrish Shrivastava
Medical Director
Dr. Ambrish, with 30+ years of experience, has worked with various Indian and multinational pharmaceutical companies like Eli Lilly, Zydus, Intas, Dr, Reddy’s and Torrent. He holds an MBBS & MD in pharmacology and has been involved in drug development, including NCEs, NBEs, and Biosimilars. He has established pharmacovigilance units and led a 60-bed facility for BA/BE studies. He has participated in audits and regulatory inspections for clinical research and pharmacovigilance. Dr. Ambrish has been instrumental in strategy and business development for new products. He is an active member of the Indian Medical Association & RSSDI, a visiting faculty at several institutions, and has 40 scientific publications. He authored a self-help book in 2020. He received the Vishisht Chikitsa Medal in 1995 and the Rashtriya Ratan Award in 2005 for community health.
Rajnish Verma
Director
GMP Services
Rajnish, with 21 years of experience, is an expert in pharmaceutical dosage formulation and quality management systems. He has worked with renowned companies like Torrent Pharmaceuticals, Lupin Ltd., and Glenmark Pharmaceuticals. His roles have involved handling deviations, CAPA, change control, validation, and qualification programs. He has also managed documentation control and GMP training programs. He has successfully led major regulatory inspections such as USFDA, MHRA, WHO Geneva, SUKL, ANVISA & SAHPRA. His proactive approach ensures comprehensive understanding, assessment, and addressing of audit findings. With extensive knowledge of the Quality system within the pharmaceutical industry and Regulatory standards, Rajnish navigates both domestic and international markets seamlessly.
Ramniwas Barua
Director
Regulatory Affairs
Mr. Ramniwas Barua is an experienced regulatory affairs professional, currently the Director of Regulatory Affairs at Pharmazone in Ahmedabad, Gujarat. With over two decades of expertise, he specializes in regulatory strategies for injectables, complex products, ophthalmic, NDDS projects, topical, solid oral, and oral liquid products in the USA, EU, ANZ, ANVISA, and India. He has a strong track record in filing and obtaining approvals for ANDA, NDA (505)(b)(2), ANDS for the USA market, and MRC, DCP, NP CP for EU markets. He coordinates with health agencies for pre- authorization activities and registration applications and participates in pre-ANDA meetings with the FDA and European agencies. Ramniwas excels in managing USFDA and other regulatory audits. Previously, he led teams at Torrent Pharmaceuticals and held key positions at Alembic Pharmaceuticals, Wockhardt Ltd., Dr. Reddy’s Laboratories, Plethico Pharmaceuticals, and Intas Pharmaceuticals. He holds an MSc in Applied Biochemistry, MBA, and Diploma in Pharmacy, with skills in risk assessment, regulatory audits, and knowledge of USFDA and MHRA guidelines.
Nirav Chandegara
Assistant Director
GCP Services
Nirav is one of the pillars in the growth of Pharmazone as he worked for a period of 5+ years at Pharmazone during his initial career. He holds 13+ years of techno-commercial experience with expertise in Market Intelligence of Clinical Study Success, Clinical Study Designing, Protocol Development, Sample Size Estimation, Pilot to Pivotal studies strategy, Pharmacokinetic & Statistical analysis, Correlating In-Vitro and In-Vivo data, Root cause analysis of clinical study fiasco, Clinical Data Slicing, Estimation of Clinical Outliers, Investigate or and Site Selection, Outsourcing of Clinical Studies, CRO Qualification & Selection, Audits, Routine, and Risk-Based Monitoring.
KOLs
Christopher Smith
Expert Advisor & Consultant
Christopher (Chris) Smith as an expert advisor and consultant to Pharmazone brings more than 40 years of pharmaceutical experience to the table, having held senior positions at the USFDA, large and small pharmaceutical companies and contract service (CMO/CRO) providers. A graduate of FDA’s Executive Development Program, he was one of the key authors of FDA’s last major rewrite of the IND and NDA regulations.
Dr Ning Li
Advisor
Dr. Li, Ning is known for his comprehensive knowledge and capability in designated portfolio of pharmaceuticals products based on the market needs and has strong life cycle management skills for each developing and developed product by allocating the necessary supportive resources. He holds a Ph.D. in Pharmaceutics, Pharmacy School, Louisiana University at Monroe. Meanwhile, he completed a short-term research work as an associate researcher in the early 2005 at Pharmacy School, UW-Madison, US. Dr. Ning Li has a strong experience in formulation development especially in controlled-release formulations and special drug delivery systems with more than 10 hard-to-do formulations launched in US and China market. Dr Li holds three patents and issued more than 15 publications in the same field. Pharmazone fondly anticipates his role towards nurturing the business and feels privileged to connect with him.
Cem Onal
Director
Cem Onal is a distinguished professional with a comprehensive background in the pharmaceutical industry. He served as the Clinical Research Director at CinnaGen İlaç
Türkiye covering a wide range of responsibilities, including clinical study planning, R&D project management, and ensuring regulatory compliance. With expertise in pharmacovigilance, GCP, and pharmaceutical industry practices, Cem has excelled in various roles, such as Director of Pharmaceutical R&D and Associate Professor at Istanbul Health and Technology University. During his tenure at Abdi Ibrahim Pharmaceuticals, Cem held pivotal roles, managing bioequivalence studies, university – industry collaborations, and regulatory affairs. His duties encompassed identifying biosimilar portfolios, managing agreements with service providers, and conducting audits of clinical and bio-analytical centers to ensure compliance with GCP and GLP standards. Cem’s academic journey includes a PhD in Analytical Chemistry, an MBA in Business Administration, and a Master’s in Pharmacology and Drug Monitoring from esteemed institutions.
Subject Matter Experts
Bhargav Dave
Deputy Manager
GCP
Bhargav is an auditor in clinical research with a varied professional history in technical aspects of clinical studies such as clinical phase, bioanalytical phase, Pharmacokinetic & statistical phase including pre-clinical phase and In-Vitro studies. He holds an M. Pharm in pharmaceutical analysis and quality assurance from GFSU. He currently oversees the GCP department routine operations including all technical aspects. He thinks it’s important to create a welcoming workplace that values equity, diversity, and creative thinking. He has a strong desire to help people realize their full potential and to better himself. His distinct viewpoint and knowledge allow us to approach problems creatively.
Pranav Sirsath
Assistant General Manager
Business Development
Pranav, a seasoned professional with over 9 years of comprehensive experience in the pharmaceutical industry, serves as the Senior Manager of Business Development at Pharmazone. With a focus on Global Regulatory and Pharmacovigilance Services, he has been an integral part of Pharmazone’s success for the past 5 years.
Pranav’s expertise spans various facets of the pharmaceutical landscape, including medico marketing and excipients firms, providing him with a deep understanding of the industry’s nuances. His hands-on experience coupled with his strategic mindset has been instrumental in driving Pharmazone’s growth trajectory.
Currently, Pranav is at the forefront of expanding Pharmazone’s Regulatory and Pharmacovigilance business globally. Through his visionary leadership, he is navigating the company towards newer heights, establishing Pharmazone as a key player in the international pharmaceutical arena.
Mohit Soni
Deputy Manager
Pharmacovigilance
With over a decade of experience in Pharmacovigilance for multinational clients, Mohit Soni has been at the forefront of advancing drug safety and patient care globally. He plays a pivotal role in overseeing the ICSR and Aggregate Report Management processes. Mohit leads initiatives aimed at enhancing monitoring systems, ensuring strict compliance with global regulatory standards, and fostering a culture of continuous improvement. Through collaborative efforts with cross-functional departments, Mohit contributes to the development of strategies that prioritize patient safety while upholding the integrity of PV practices.”
Kanhaiyalal Patil
Manager
Engineering Services
Kanhaiyalal Patil is a CGMP Consultant and HVAC Validation & Calibration services professional based in Ahmedabad, Gujarat, India. With several years of experience in the pharmaceutical industry, Patil has expertise in green field project work, QMS updating, Qualification/ Validation & CSV activity, Deviation/ CAPA handling, Risk assessment, Documentation control and Lab maintenance. Mr. Patil has worked with various Multinational and Domestic companies like Wockhardt Ltd, Boston Vietnam Pharmaceutical JSC., BRASSICA PHARMA PRIVATE LIMITED, ETC. Mr. Patil holds a Bachelor’s Degree in Engineering from North Maharashtra University.