LBR Regulatory

LBR Regulatory and Clinical Consulting Services (LBR) was founded in 2001 by Lois B. Rosenberger, M.S., Ph.D. on the belief that a team of experienced professionals, who were driven by a hands-on work ethic, and were unencumbered by the administrative processes of a larger company, could deliver higher quality regulatory and clinical services in a more cost-effective manner. Lois also believed that a quality product, at a fair price, would be well received by the pharmaceutical industry. Since 2001, LBR has held true to this basic principal, and this dedication has been rewarded with a steady flow of repeat business from satisfied clients and from new clients referred by satisfied clients. LBR continues to provide full regulatory services, strategic planning, full project management of clinical trials, and general drug development consulting services at competitive rates to pharmaceutical companies of all sizes, from start-up and small companies to medium-sized drug, device and biotech companies who lack in-house resources in these areas, to large pharmaceutical companies addressing a shortage of in-house expertise. LBR also provides ancillary services, including clinical project management, monitoring, clinical report and submission writing, quality assurance auditing, GMP and GLP auditing, and dossier and position paper preparation to pharmaceutical companies. To small, medium and start-up pharmaceutical, biotech and veterinary companies, LBR provides the advantage of a specialized array of regulatory and clinical services in a framework that allows a tailored, cafeteria-style approach. This concept allows these small to mid-size companies to reap the benefits associated with in-house regulatory, compliance and clinical project management expertise without the long-term commitment of maintaining salaries and other benefits. LBR's team of experts, and its fair-pricing philosophy, provides start-up and small-to-medium sized pharmaceutical and device companies, the opportunity to control costs, but not to forego critical regulatory and clinical services. With its team of experienced professionals, LBR can provide these smaller companies de facto regulatory, clinical project management, monitoring, and compliance departments. For larger companies, LBR provides a ready source of experienced professionals who can augment in-house personnel to meet peak workload demands in the areas of regulatory document writing, project management, monitoring, medical/scientific writing, submission preparation, and auditing, as needed. This provides the client with rapid response options to meet temporary workflow peaks without increasing in-house resources. LBR is committed to staffing every project with the most qualified and experienced personnel available and to ensuring that each project receives the required attention. LBR recognizes the importance of every project to the client and is committed to taking on new projects if doing so will not compromise the staffing or quality of an ongoing project.