Tani Consulting, LLC is a CMC and Quality consultancy specializing in the pharmaceutical and biotechnology industries. With over 25 years of industry experience we work closely within Operations and Quality organizations to be the "bridge between the science and regulations" to ensure a strategic, risk based, scientifically driven approach. We build Quality systems and CMC processes that are scientifically sound, efficient, and regulatory compliant from early to late phase development. We specialize in the areas of CDMO selection and management, process development, drug substance & drug product manufacturing, analytical development, formulation development, comparability, validation, technology transfer, CTM labeling, distribution & inventory control, QC, worldwide CMC regulatory submissions, building quality systems, audits, training and, QAA's.