Robb Giddings has extensive experience advising life sciences and healthcare companies across the regulated-product spectrum: pharmaceuticals, human cells and tissue products (HCT/Ps), medical devices, laboratory developed tests (LDTs), clinical decision support and health software, cosmetics, food, dietary supplements, and hemp and cannabis. He also counsels contract research and manufacturing organizations (CROs and CDMOs), and pharmacies.

His clients have ranged from bootstrapped startups, including one he founded himself, to international pharmaceutical companies with billion-dollar product portfolios, and every size and lifecycle stage in between. That range shapes how he practices: he focuses on finding innovative and efficient legal solutions that fit a client’s unique goals, operations, and culture.

Robb’s practice centers on:

• Federal healthcare compliance – strategic analysis and advice; compliance program design, build, and implementation; compliance monitoring, investigation, and training; and payment transparency
• State healthcare compliance – licensing and permitting; price transparency reporting (new drug, price increase, and WAC reports); stewardship and takeback requirements; sales representative registration and reporting; annual compliance certifications; spend limits; and payment transparency
• Commercial contracts
• Product development, clinical trials, and human research
• Marketing and promotion
• Strategic transactions and integrations
• Building and running a legal function – streamlining legal and compliance operations, and hiring, mentoring, and managing attorneys, paralegals, and staff

Before joining Outside GC, Robb served as Deputy General Counsel, Acting General Counsel, and Interim Compliance Officer of QOL Medical, a specialty pharmaceutical company. In those roles, he designed and implemented legal and compliance templates, processes and procedures, and technology solutions that allowed the functions to efficiently scale with the company’s rapid headcount and revenue growth. He also coordinated the defense of the company and its executives in a DOJ investigation, which was resolved without admission of liability, and then successfully implemented the resulting Corporate Integrity Agreement (CIA).

Prior to QOL Medical, Robb was a Senior Associate in the Life Sciences Practice Group at Hutchison PLLC, where he established, led, and grew a Florida office and a new FDA and Healthcare practice at the firm. He advised clients on legal, regulatory, compliance, and strategic matters involving a broad range of life sciences and healthcare businesses. He also served as outsourced General Counsel, Compliance Officer, Privacy Officer, and Board Advisor for a range of clients. Earlier, he practiced at Life Sciences Law PLLC.

Robb has also held Legal Counsel roles at AbbVie and PRA International (now ICON). At AbbVie, Robb supported clinical development programs across five therapeutic areas, including multiple blockbuster drugs such as Humira®, Rinvoq®, Androgel®, and Viekira®. He received a President’s Award (AbbVie’s highest internal award) for helping design and implement strategies that cut clinical trial site activation timelines by an average of 50%. At PRA, he supported clinical development, compliance, and regulatory initiatives across the company’s service offerings and its clients’ investigational drugs, biologics, and medical devices. He also received a President’s Award (PRA’s highest internal award) for serving as lead internal attorney on PRA’s international expansion into China via a joint venture with Wuxi AppTec.

Alongside his legal practice, Robb consults on regulatory and special projects for Medispend, a SaaS compliance solution provider. In this role, he helps update and improve compliance software solutions and managed service offerings; maintains a regulatory digest of applicable state price transparency reporting laws, regulations, and agency guidance; and prepares summaries and training on new laws, regulations, and enforcement trends.

Robb earned his J.D., cum laude, from Duke University School of Law, and his B.S. in Chemistry, with a Biochemistry focus, from the University of North Carolina. He is admitted to practice in Tennessee, Florida, North Carolina, and Massachusetts (inactive).

Robb, his wife, and two fur babies (dogs) live in rural Tennessee near the Kentucky border, where they embrace the outdoors: biking, hiking, camping, climbing, and more. When they have the chance to travel, they enjoy scuba diving and trekking.