Mandava Associates is a Washington, D.C. based consulting firm and was formed in 1986 by our Founder and President, N. Bhushan Mandava. Mandava Associates is an organization of highly qualified professional consultants with over 20 years of government and industry related experience. We understand the inner workings of various governmental agencies as well as realistic concerns involved in manufacturing of products. Mandava Associates provides comprehensive regulatory services to clients for U.S. and international product submissions, registrations and approvals. We provide advice and strategies for product development and manufacturing of various chemicals, medical devices, biological, pharmaceutical, and biotechnological products. Our staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, CMC and compliance, QA/QC, statistics/data management, project management, clinical monitoring, clinical trial design and evaluation, science and health policy.