Nivagen Pharmaceuticals, Inc.

🚨 Webinar Announcement! 🚨 #Nivagen Pharmaceuticals Inc. is proud to present an exclusive session on in-house, rapid, and cost-effective contamination control strategies in pharmaceutical manufacturing. Join our experts — Nilkantha Banerjee, MS, MBA, PGD (Director of Microbiology), Olivia Matsumoto-Elliott (Microbiologist) , and Adam Peters (Microbiologist) as they share key learning points: 🔆 Learn how global regulatory bodies define and assess CCS, and what compliance looks like in modern pharmaceutical environments. 🔆Explore how innovations such as automation, data analytics and real-time monitoring are transforming contamination control practices. 🔆Discuss projections for industry evolution, including advancements in rapid testing methods and their implications for quality assurance and operational efficiency. 🔬 This is a must-attend for professionals in microbiology, quality assurance, and pharmaceutical manufacturing who want to stay ahead in compliance and innovation. 👉 Register now to secure your spot! https://lnkd.in/ekqkrPit #ContaminationControl #Pharmaceuticals #Innovation #QualityAssurance #Nivagen #Nivagenpharma

Last week, we were pleased to share that our aseptic operations team participated in an external training session led by Jim Polarine Jr., Principal Consultant, Technical Services at STERIS Corporation. This insightful session strengthened our team’s expertise and reinforced our commitment to industry best practices. A big thank you to Mr. Jim for sharing your valuable knowledge and perspectives! #nivagen #pharma #trainningsessions #asepticoperations #steris

Reflecting on the PDA - Parenteral Drug Association Regulatory Conference 2025, we are inspired by the remarkable alignment between industry leaders and regulators in shaping the future of pharma. Together, we’re championing lean organizational structures, simplified processes, and an unwavering commitment to data integrity. The transformative power of AI was front and center, as experts highlighted how digital innovation is redefining quality management and setting new standards for compliance and patient safety. Nivagen Pharmaceuticals Inc., under the visionary leadership of Jay Shukla, proudly joined the conversation alongside Robert Dream and Nilkantha Banerjee, MS, MBA, PGD Our team remains dedicated to advancing cutting-edge technologies and fostering an open, innovative culture. The shared vision for 2030—safe, effective, and affordable medicines for all, driven by digital transformation—was echoed by key regulatory and industry leaders in attendance. We look forward to embracing change and collaborating to deliver on this promise for patients worldwide. Our team met with several influential FDA officials, including Carmelo Rosa [Division Director of Quality of Manufacturing and Product Quality (OC, CDER)], Peter Baker [former FDA expert in data integrity, accountancy, and quality risk management] Ivy Sweeney, Ph.D. [Acting Director of Quality of Human and Animal Drug Inspectorate (OII)], Tara Gooen Bizjak [Associate Director of GMP and Quality Standards (OC, CDER)], Jill Furman [Director (OC, CDER)], Cindy L. Burnsteel [Deputy Director of Drugs and Devices (OSC, CVM)], Melissa J. Mendoza [JD Director, OCBQ, CBER] and Jeffrey Meng [Associate Director of Imaging Technologies and Advanced Manufacturing for Medical Products Inspectorate (OII)]. Leaders from across the industry came together to understand real challenges and discover solutions for the next level. #PDA #PDA2025 #pharma #pharmaindustry #FDA #industryleaders #CDER

💼 Happy Labor Day! 💼 Today we honor the power of persistence, the spirit of teamwork, and the pride in doing work that matters. Wishing everyone a restful and meaningful day! #laborday #nivagenpharma #pharma

🌟 Join us in welcoming Rajesh Gurjar to the Nivagen family! We're excited to have you on board and look forward to the great things you’ll accomplish. Welcome to the team! #Nivagen #NivagenPharma #NewTeamMember

🌟 Join us in welcoming Antara Rath to the Nivagen family! We're excited to have you on board and look forward to the great things you’ll accomplish. Welcome to the team! #Nivagen #NivagenPharma #NewTeamMember

🌟 Join us in welcoming our new Microbiologists to the Nivagen family! We’re excited to have you all on board and can’t wait to see the great work you’ll accomplish together. Welcome to the team! 👏 #Nivagen #NivagenPharma #NewTeamMembers

Last week, our Nivagen India team had a wonderful time enjoying the summer weather while bonding over some exciting outdoor adventures! 🌞🧗 #nivagen #nivagenpharma #teambonding

🌟 Join us in welcoming Ankit Mehta to the Nivagen family! We're excited to have you on board and look forward to the great things you’ll accomplish. Welcome to the team! #Nivagen #NivagenPharma #NewTeamMember

🔆We are thrilled to welcome Robert Dream to the Nivagen family! Mr.Robert Dream brings with him a remarkable legacy of over 30 years of leadership in the pharmaceutical, biotechnology, and advanced therapeutics industries. As a Registered Professional Engineer in multiple states, his unmatched expertise, visionary thinking, and deep industry insight are truly invaluable. Throughout his career, Robert has driven innovation across vaccines, ATMPs, oligo/mRNA technologies, and more—always with a strong commitment to collaboration, regulatory excellence, and operational transformation. His leadership extends globally, having guided complex regulatory strategies, managed large-scale capital projects, and shaped best practices through his work with industry organizations like ISPE and PDA. Beyond his technical brilliance, Robert is a mentor, team-builder, and thought leader—consistently championing a culture of excellence and growth. We are excited for the journey ahead with Robert on board and confident that his expertise will further elevate Nivagen’s mission to make a lasting impact in the life sciences space. Welcome aboard, Mr.Robert Dream! #Nivagen #Nivagenpharma #newteammembers