manufacturers, packaging providers, contract manufacturers, distributors, and analytical laboratories. SH Consulting delivers risk management and quality risk analyses, including application of guidelines for elemental impurities, excipients, audit frequency, and issues such as nitrosamines. The firm also supports data integrity programs and operational quality assurance activities, from documentation to inspection readiness. In addition, SH Consulting designs and delivers training on good manufacturing and distribution practices and specific risk analysis topics, and provides support for qualification, validation, and purchasing processes.