Vice President of Strategy and Operations
A Visionary “IT/Business Strategist & Value driven Executive” with over a decade of diversified experience in delivering successful programs across both Private and Public sectors. His core expertise is rooted in developing innovative, fact-based, realistic solutions and performance based operating models to bridge business demands with robust IT strategies. He is known by his clients and peers as the ‘Trend Setter’ for solving complex IT/Business challenges through the use of innovative technologies and industry proven business practices. Additionally, his areas of expertise and experience include: Business Analytics, Business Process Re-engineering, Contract Management and Administration, Quality Management, and Project/Program Management in both Federal and Commercial Markets. Mr. Singalla is a certified Project Management Professional, Certified Scrum Master, Certified Six Sigma Green Belt Professional and holds the ITIL v3 Foundations certificate. He has a bachelor’s degree in IT Engineering and holds a Masters in Business Administration.
As an avid enthusiast and advocate for “Meaningful Mentorship”, where the emphasis is more on a holistic mentoring approach focusing on both personal and career transformation, Praveen spends his free time conducting seminars, boot camps and workshops on various business, IT & personality development topics focused on empowering individuals with the will and desire to succeed in life. He is also actively involved with various non-profit organizations in India and here in the US; serving the needs of under-privileged kids to pursue education.
Dr. Mukesh Kumar, PhD, RAC
Chief Innovation Officer
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about more than 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.
Manager, Work Management Services
Noopur is a proactive and customer focused senior program manager with over 10 years of experience in all aspects of program management and management consulting across multiple federal agencies and large global organizations. She served as the lead in the Workfront implementation and support project at the Food and Drug Administration (FDA), Federal Trade Commission (FTC), as well as a multitude of commercial organizations. Her experience affords her the ability to quickly and accurately assess complex situational challenges, develop creative technical solutions and implement them in a manner that keeps disruptions to operations to an absolute minimum.
Rakshith is a Washington D C based pharma regulatory affairs specialist has applied project management principles towards approval pathways associated with Drugs, Medical device, and Biologic’s. Rakshith has acquaintance with project process groups such as initiation, planning, execution, and closing and knowledge areas needed to manage any project through a complete project life cycle. He has the capacity to distinguish between project, program, and portfolio management. Complete understanding of US FDA Regulations, cGMP, GCP, ICH, Regulatory submissions (IND, NDA,BLA,510(K), PMA), and Regulatory strategies, He has comprehensive experience in documentation and record maintenance and possess In-depth understanding about general mechanics of clinical trial, insights on content of clinical trial application, marketing authorizations, role of human subject in research, considerations for international clinical trials, trial ethics, and awareness of legal liabilities of sponsor during clinical trials.
Rakshith is highly knowledgeable about new drug development process which includes Pre-IND, IND, NDA, MAA, and SPA to obtain marketing approval and capability to support cross functional activities and conduct regulatory intelligence required to support development and implementation of short and long term strategies.
Mehul Gulati is a dynamic Project Manager who leads complex, multifunctional teams in the development and implementation of strategic solutions that increase efficiency, reduce costs, and enhance the bottom line. An analytical leader who rapidly determines business needs and proposing innovative solutions, he has a reputation for seamlessly creating and implementing strategic business plans while exceeding corporate goals, and objectives.