Sally Gu

Sally Gu

Senior Associate Global Regulatory

Washington, D.C.

+1 202 637 6856

[email protected]

Languages

English

Sally Gu

Overview
Experience
Credentials
Insights and events

Sally Gu takes a practical approach to help clients navigate the intersection of pharmaceuticals and biotechnology law, compliance, and commercial strategy. She leverages her experience from multiple in-house rotations to develop practical solutions that address her clients' most complex regulatory issues, ranging from current good manufacturing practices (CGMP) and quality risk management to drug commercialization and brand strategy.

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.

Representative experience

Lead internal investigation and presentation to government regarding whistleblower complaints relating to product quality issues.

Conduct compliance reviews for pharmaceutical companies of Commercial and Medical organizations, promotional materials, promotional review processes and investigator initiated study programs.

Counsel companies on pre-launch and post-marketing activities, including advice on claims assessments, patient support programs, HCEI strategies, and promotional and medical materials review.

Assist multiple pharmaceutical companies in responding to FDA enforcement letters, Form FDA 483 inspectional observations, related government investigations and consent decrees.