Departments devoted to service
Quality and Corporate Compliance
Upsher-Smith’s dedicated and experienced staff is focused on ensuring the highest quality products and services for their customers. Our capable Quality teams work collaboratively throughout the product lifecycle embracing continuous improvement and encouraging innovation and flexibility to enhance organizational excellence, drive industry competitiveness, and surpass expectations for regulatory compliance. Upsher-Smith has developed and implemented its quality system to ensure control of the development, manufacture and distribution of all of our products to best meet these needs. With an emphasis on prevention and issue resolution, the company’s rigorous compliance program has established a credible rapport and partnership with key regulatory stakeholders at FDA (headquarters and district levels), DEA and state agencies.
Marketing and Sales
Commercial teams are a core strength at Upsher-Smith. They serve as a direct link between USL’s corporate commitment and their customers. Marketing evaluates the market conditions and implements strategies to ensure that the products satisfy unmet customer needs. USL’s highly trained sales teams educate physicians and pharmacists on the patient benefits of Upsher-Smith’s products.
Pharmaceutical Research and Development
Pharmaceutical Sciences is responsible for developing the chemistry, manufacturing, and controls required to support regulatory filings for new Upsher-Smith products. Key activities include API (active pharmaceutical ingredient) synthesis assessment/development, formulation and process development, scale-up to manufacturing, analytical method development and validation, and product specification development.
Upsher-Smith’s manufacturing resources include 550,000 square feet of manufacturing and storage capacity in three state-of-the-art cGMP pharmaceutical manufacturing facilities located in Minneapolis, Minnesota, and Denver, Colorado, where quality and customer service are the focus. All of the products manufactured at these sites are produced to the highest industry standards by people who are passionate about quality. Operations group includes Supply Chain, Manufacturing, Engineering and Technical Services.
Clinical Research and Development
Clinical Research and Development conducts clinical trials to evaluate safety, efficacy, and the value of new drugs. In addition, they conduct studies of marketed drugs to define how they can be most effectively used, to evaluate their utility in new indications, and to continuously assess their safety profiles.
The Upsher-Smith Medical Affairs team supports the business by providing strategic scientific expertise and executing effective scientific messaging while maintaining compliance with applicable rules and regulations in order to drive appropriate product utilization and disease treatment.
Our Regulatory Affairs team provides strategic scientific and regulatory expertise driving the evaluation and maintenance of Upsher-Smith’s healthcare products in various phases of development and marketing. Regulatory Affairs is a primary liaison and negotiator, on behalf of Upsher-Smith, with health agencies (eg, FDA). Regulatory Affairs is responsible to ensure that global regulatory compliance is maintained in accordance with applicable rules, regulations, and guidelines.
The Upsher-Smith Legal Affairs team is responsible for the direction and management of all legal aspects of Upsher-Smith’s business/legal strategy. The team is responsible for a broad range of activities including negotiating (or directing negotiations) and managing corporate licensing and strategic partnership arrangements; managing litigation; developing, implementing, and supporting corporate compliance programs; and conducting legal and business risk assessment analyses. Legal Affairs manages company intellectual property including patents and trademarks, manages disclosure of confidential information, and provides independent advice and direction to the Upsher-Smith management team.
Upsher-Smith understands that people are its most valuable resource and are vital to the success of the company. The Human Resources team works with key leaders within the organization to create an environment conducive to innovation, teamwork, quality, and productivity. Upsher-Smith partners with business units—functional leaders and employees—to design and execute initiatives that positively impact business outcomes in 5 key areas (our “HR Strategy”): 1) Culture Management, 2) Talent Management, 3) Workforce Planning, 4) Total Rewards, and 5) Employee Well-being. It is through this strategy that HR contributes to the Upsher-Smith vision.
The Finance team is focused on 3 key areas: 1) processing financial transactions and maintaining the Company’s financial records, 2) creating and managing control over Company resources, and 3) partnering with other functions to provide value-added support. They provide management with the relative financial value of competing options as another key input into its decision-making process. Providing timely, high-quality decision support is their goal.
The IT organization is composed of people, processes, and technologies. They partner with business colleagues throughout the company to define, build, implement, and support information tools that solve problems and deliver real business value.