NexAge Technologies USA Inc, (NEXAGE) is a well-established, global Life Sciences Technology Solutions organization. The services provided by NEXAGE include: Regulatory compliance, IT Audits, Validation services and Quality Assurance, Big Data Analytics, Data Migration, Supply Chain, and BI solutions to FDA regulated industries including pharmaceutical, biotechnology, medical devicesorganizations. The clients we have served include Hoffman Roche, Bausch+Lomb, and Phillips Lifeline Systems. We support organizations in the regulated industries comply with Federal /FDA regulations in their computer systems, documentation, processes, and procedures
NEXAGE brings years of relevant experience and deep understanding of the various challenges that cGxP regulated industry face. As a committed team of validation and regulatory compliance specialists, we have our clients covered in most aspects of compliance and validation. We are committed to deliver the high level of compliance required by Life Sciences organizations. Our goal is simple: earn the trust of our clients by consistently exceed expectations. Our industry knowledge, integrity, excellence in execution, competitive pricing models, and quick results are distinct advantages.
For more than a decade NEXAGE has been providing challenging career opportunities to professionals with world’s leading companies. Our employees have the knowledge and expertise to help companies reach business goals in specific areas of Clinical Research & Development, including Clinical Operations, Pharmacovigilance, Medical Writing, Clinical IT, Biometrics, Regulatory Affairs, Big Data, BI, and more.
We have distinct competitive advantages due to multiple factors such as:
We have earned a stellar reputation in the industry as a reliable organization that consistently delivers high quality results. The company has built its consulting business around exceeding client expectation of quality and service. By focusing on quality and going the extra mile to provide superior client service and support, NEXAGE has effectively differentiated itself from competition. Our unique organizational culture that is based on common values, high levels of trust, integrity and ethics attracts clients as well as high quality IT professionals. Our attractive compensation and benefits fosters loyalty and generates referrals that have become a major source of new business as well as new employees. NEXAGE supplements its strategic IT consulting practice by a highly effective, proprietary internal training and development program that equips and cross trains our employees with the latest version of cutting edge technologies, processes, applications and also with the leadership skills required to successfully execute on strategy.
Special mention for NexAge Technologies USA Inc. and its Leadership
Dr. Suresh Kumar; Co-Founder
A Deloitte Fast 50 and 5 times INC 500/5000 ranked serial entrepreneur, Suresh Kumar is an engaged-scholar deeply immersed in entrepreneurial practice, research, learning, and policy. He is the founder of two Inc 500 ranked high-growth technology startups- NexAge Technologies USA Inc and Green Earth Technology Solution LLC. Suresh completed his doctoral degree in 2011 and has conducted professional development workshops, presented papers, and mentored at the Academy of Management Annual Conference (AOM), the Babson College Entrepreneurship Research Conference (BCERC), the International Council of Small Business (ICSB), the Australian Center for Entrepreneurship Exchange (ACERE), the Startup Weekend, INC, and the TIE Institute. He is an advisor to several social sector organizations that are focused on large scale social change including Ashoka, The Indus Entrepreneur (TIE), and South Asian Americans Leading Together (SAALT). Currently Suresh serves as Senior Advisor, Corporate Strategy at 8K Miles Software Services Inc. An expert in the lean startup methodology, he mentors students at Eugene Lang entrepreneurship center at Columbia Business School, and the Pacific Asian Center for Entrepreneurship, University of Hawaii.
Usha Agarwal – SVP, Business Development and Sales
Usha Agarwal joined NexAge in 2004 in Sr. Manager, Sales and Business Development. During the last 10+ years due to her outstanding performance and dedication she have been given in various roles and responsibilities, promoted multiple times and is a recipient of the NexAge Most Valuable Professional (MVP) Award in 2005. Usha is driven, goal oriented, meticulous and taking charge come naturally to her. Usha's passion is to run a profitable business, grow employees and achieve the highest customer satisfaction. Outside of work, she devotes time to the elderly in her community to assist them in adopting the internet. She mentors young women to develop negotiating skills to help them in their professional and personal lives and derive pride and inspiration from their success. Usha completed her MBA from NYU Stern Business School in 2014 with specializations in Finance, Strategy and Marketing.
Dolores Leonard - VP, Admin and Accts
Dolores or “D” as she is called within NexAge has over 20 years professional experience in Administration, Accounts, and Financial Management. She joined NexAge in August 2000 as a Secretary and in a short span of 10 years worked her way up to becoming Vice President. She is currently responsible for managing the financial, accounts, administrative and employee services of the company. In 2001, as an acknowledgement of her outstanding service, dedication, loyalty, and commitment to the company, Dolores was awarded the Most Valuable Professional (MVP) Award in 2001.
Arunkumar Sreekumar - VP, Services
Arunkumar is an Electronics Engineer with over 17 years’ professional experience in India, Middle East and US. He started his career as a System / Database Administrator and has since acquired domain knowledge in Healthcare, Supply Chain Management, Pharma and Life Sciences Industries. Arunkumar has high level expertise in resolution of technical issues and implementation of software products. He has been working with NexAge over 11 years and currently heads the recruiting team in the niche technologies for the Life Sciences domain. Arunkumar is a winner of the NexAge Most Valuable Professional (MVP) award in 2006.
Aruna Gamini – Assistant VP, HR
Aruna has more than 8 years of hands on experience in US Immigration laws. She began working in the field of corporate and business immigration law while working as an In-house Immigration Manager in various technology services firms. Over the years she gained substantial experience in non-immigrant and Immigrant filing; drafting petitions, applications and specialized support letters detailing eligibility for visa classification and other immigration benefits. Aruna is a strong team player with excellent client facing with the ability to communicate complex sensitive information in an understandable form. Aruna graduated with a Master of law degrees from Osmania University in 2015 from Touro Law College Jacob D. Fuchsberg Law center, New York.
Srinivasan Bhaktavachalam - Sr. Project Manager
Srini- as he is known within NexAge- is one of the first technical employee hired by NexAge in 2001 and is highly respected for his professionalism, integrity, and humility. He began his career as a Software Developer Engineer in 1998 with Virgosys Software in his home town of Bangalore, India. Soon he developed expertise in Web Development using Microsoft Web Technologies and in Relational Database Design. His subsequent employment with System Solutions and Federal Technologies established his career not only as a talented software engineer but also a team leader who lead by personal example. Srinivasan started his career with NexAge in 2001 leading a large product teams in India and USA. At NexAge Srinivasan had the opportunity to Design, Develop and Implement software solutions for corporate clients like TD Waterhouse, Schering Plough, Merck & Co. Srini has been awarded with the NexAge is a recipient of the NexAge Most Valuable Professional (MVP) Award in 2001 and is currently on assignment with Merck & Co, NJ.
Guru Shastri - Advisor, Compliance, Governance, and Audit Practice
A pharmaceutical industry expert, Guru has provided simple and sustainable solutions for better corporate governance, productive information assets, and robust technology infrastructure for over 15 years for companies such as Roche Pharmaceuticals, Celgene, Johnson & Johnson, McNeil Healthcare, CVS Caremark, Actavis, Ernst & Young Life Sciences. A MBA graduate from Dowling College in Long Island, NY, Guru Shastri brings in-depth knowledge on corporate compliance and governance in the healthcare industry. In the pharmaceutical world, Guru has worked extensively on technologies used for Drug Safety, Manufacturing and Distribution, Drug Discovery and Development and Post Marketing Surveillance. Having extensively worked directly with Health Regulatory Authorities in US, EU and Canada, Guru Shastri brings valuable knowledge in providing cost cutting compliance solutions which include Resource Allocation Assessments, Technology Assessments, Project Management, Internal Audits, Cost / Benefit Analysis, Computer System Validation and Quality Assurance. Guru is a recipient of the NexAge Most Valuable Professional (MVP) Award in 2006
Saravana Sunder – Asst. VP, Safety And Quality Management
Saravana is a result oriented Senior Quality Management Leader with 15+ years of diverse experience across GRC within the regulated life science healthcare industries. Highly proficient in building a robust quality management system for small to mid-size life sciences companies by balancing regulatory needs while increasing business value. An active participant within the Global Quality leadership community involved in translating regulations to process implementation steps as impacted by new technologies. Senior Lead Quality Auditor engaged by big pharma to audit and make recommendations for validation process improvements and to strategize closing gaps from legacy system packages. Experience for multiple global implementations across infrastructure (including migration of data centers and migration to cloud), clinical, lab and manufacturing areas. He has worked with Schering plough, Merck, Genentech, Roche, Baxter, Bayer, currently with Hospira/Pfizer. Saravana is a recipient of the NexAge Most Valuable Professional (MVP) Award in 2007.
Naresh Desai- Advisor, Instrument Validation Practice
Naresh has extensively worked in regulated environment and excels in system implementation per following guidelines: 21 CFR Parts (11, 58, 210, 211, 312, 314, 820), ICH (Q7, Q8, Q9, Q10, E2B), USP 1058, ISO (13485:2003, 14971:2000), GAMP (4, 5, Computerized Lab Instrumentation), and EU guideline (Part I, Annex 7, Annex 11, Annex 20). He provided leadership to implement Laboratory Instruments, Equipment Manufacturing, Computerized system Validation with risk based approach along with process improvement, audit readiness and implement quality management system in healthcare industry. Naresh has worked and managed teams to implement the several cGxP and quality systems at Abbott Vascular, Agensys, Amgen, Biogen Idec, Cordis (J&J’s Company), Gilead Sciences Inc, MedImmune Inc (AstraZeneca’s Company), and SAIC-Frederick Inc (NIH and NCI’s company). Naresh is a recipient of the NexAge Most Valuable Professional (MVP) Award in 2007.
Mahendra Sangani - Lead, Validation And Training
Mahi- as he is called within NexAge is a IT Compliance Expert with experience as Validation Engineer (CSV)/Business Analyst and Project Manager in a wide range of projects for Laboratories, Pharmaceutical, Biopharmaceutical and Medical Device Industries. Proficient in Regulatory Compliance Policy (GRC) policy which is a lean and agile approach governing best practices and high level business direction for the design, implementation, testing and deployment of software systems. He is well-versed in various regulations governing Electronic Records and Electronic Signatures. Mahi was responsible for the several global implementation and validation of IT systems at Johnson & Johnson, Roche, Quintiles, Inventive, Synergisitix. He is also experienced in validation of cloud based Pharma solution provided by Veeva, Medidata and Salesforce.com. With his practical experience and sound understanding of the industry best practices he trains client and colleagues on concept/methodology of Computer System Validation and Software Development Life Cycle in the Pharmaceutical Domain. Mahi is a recipient of the NexAge Most Valuable Professional (MVP) Award in 2009.