Sally Gu

She routinely advises pharmaceutical and biotechnology companies at all stages of the compliance spectrum, helping clients anticipate regulatory challenges in day-to-day business operations, navigate the remediation process, and develop strategies for sustainable compliance.  

Sally applies her broad experience working with teams across all levels of pharmaceutical organizations, from shop floor personnel to executive management, to provide compliance and enforcement advice to companies facing critical CGMP and quality issues.  She supports clients with developing strategic communications with government agencies, preparing for site inspections, and managing complex manufacturing facility and quality system remediation projects.

She also guides client decisions about drug promotion, omnichannel marketing strategies, patient support programs, and comprehensive pharmaceutical compliance programs.  Sally works on major investigations into off-label promotion, client responses to FDA warning and untitled letters, competitor complaints, and privileged compliance reviews of Commercial and Medical organizations.

Her in-house experience includes supporting a drug product launch for a global pharmaceutical company with more than >$45B in revenue, and providing legal and operational support for multiple business segments within a major global medical product distributor.