SOURCE: US Data Management
SANTA BARBARA, CA--(Marketwired - Apr 24, 2013) - USDM, a leading global regulatory consulting firm in the life sciences space, is proud to welcome Kevin Foley, Senior GMP Auditor and Quality Subject Matter Expert. While Kevin will be predominantly involved in Quality, Auditing & Quality Management Systems engagements, he will also utilize his expertise in the Laboratory, GRC and Training areas to assist in meeting our client's quality and compliance needs in these key practice areas.
With the addition of Kevin Foley and his FDA expertise to our Quality & Auditing Practice, USDM offers an un-paralleled combination of experience and skills across the entire drug development lifecycle from API/Excipient manufacturing to Phase I to analytical/stability testing to pivotal trial batches to scale-up, bioequivalence/bioavailability batches, Pre-Approval Inspection Readiness, contract manufacturing to manufacturing of commercial products. Said Robert C. Lesnefsky, VP, Global Regulatory Compliance, Quality Assurance and Auditing.
"This is truly an exciting opportunity," said Foley. "USDM is the leader in helping life sciences companies embrace technology that enables them to get products to market faster; content and collaboration are critical components to achieve this end. With this outstanding team and unparalleled approach, I believe we are well positioned to help our clients manage the complexities of delivering predictable results and efficiently utilizing resources, while at the same time reducing risk and improving the bottom line. My goal is to leverage the strongest skill-sets in the industry that the USDM team brings to the table along with the experience and vision our clients need to grow in these challenging and exciting times."
Foley's extensive experience includes: Conducting Drug GMP (Parts 210, 211, ICH) inspections (world-wide) of API and sterile finished drug manufacturers, OTC drug manufacturers, medical gas manufacturer's facilities, homeopathic drug and dietary supplements; Conducting BioMedical Organization (21 CFR Part 50) inspections of clinical investigators, sponsors, IRB's, CMO's and CRO's (GCP) and GLP laboratories; Conducting GMP and Pre-Approval inspections of API manufacturing drug firms and control laboratories in India, China, United Kingdom (Northern Ireland, Scotland, and England), Ireland, Austria and France as well as leading Pre-Approval inspections in support of novel molecular entities, ANDA's, combination drug/devices and high-risk/high-profile firms focusing on multi-profile/6 systems approaches.
USDM is a leading global regulatory consulting firm providing compliance, business intelligence, validation, qualification, quality, auditing, and IT services to our clients in the life sciences industries. USDM has partnerships, expertise and solutions for critical Life Science technologies -- Oracle, SAP, ServiceMax, Salesforce, Microsoft, Qumas, and others. USDM has more than 12 years of experience supplying our clients with compliant solutions in each phase of their drug and product development cycle, partnering with best of breed ISVs to help companies unify and optimize their business and compliance processes.