USDM LLC: Driving Business Performance across Product Development Lifecycle

Given the complex landscape of evolving regulations combined with the rapidly changing life sciences marketplace, chief executives of today’s leading companies are challenging traditional ways of conducting business to ensure a competitive supply chain, promote customer confidence and enable growth. One such area where traditional programs are coming under increased scrutiny for adoption over non-traditional solutions is Governance, Risk, & Compliance (GRC). “Corporate accountability is placing increasing demands on the adoption of a GRC strategy to provide stakeholders the confidence that their business is being run in a reliable, compliant and sustainable manner. A comprehensive GRC program can save time and money by unifying approach to design and implement effective controls and risk mitigation tactics,” says Kevin Brown, co-founder and Managing Partner of US Data Management (USDM).

USDM provides solutions for life sciences companies to tackle GRC challenges. It applies practices to identify GRC threats and build a protective framework of policies, controls, and risk mitigation strategies. In addition, it provides life sciences expertise to integrate FDA computer system compliance into GRC program. The company’s Validation Accelerator Packs streamline the process of implementing computer systems in compliance with GxP regulations and help consolidate the overall enterprise compliance strategy when combined with GRC Manger. USDM specializes in compliance and implementation services in the life science industry. Within this space, the company provides vendor selection, GAP analysis, project management, computerized system implementation and validation, and procedure development to its clients and partners.

USDM addresses the critical areas of operations for pharmaceutical and medical products companies. “We proactively work with clients to identify how to drive higher levels of business performance across the entire product development lifecycle,” says Brown. It implements solutions that support regulatory intelligence and knowledge management throughout the research and development and administrative processes. The company help clients improve the quality, efficiency, and compliance in the development of new medical products; streamline the development of submissions and preparation for interactions with regulators; enhance the quality of information provided in managerial submissions; and accelerate administrative authority review and approval.