Product specific regulatory/compliance and clinical advice and strategy at the early stages of product development can be critical to the ultimate approval of the product. Failure to address regulatory and compliance concerns early in the development program often results in delays in approval due to improperly designed studies, omitted studies, manufacturing oversights and other failures to meet key regulatory requirements.

LBR addresses the regulatory and strategic drug development needs of pharmaceutical companies of all sizes.

LBR has a team of experienced professionals, driven by a hands-on work ethic and unencumbered by the administrative processes of a larger company, who can deliver a high quality product in a timely manner at a reasonable cost. Our team provides Regulatory Services, Quality Control, Quality Assurance, Report Writing and Training Services for the Pharmaceutical Industry.

Areas of experience include Veterinary Medicines, Over-the Counter Medicines, Prescription Drugs, Biologics and Medical Devices.

LBR Major Accomplishments

In 2001, LBR provided Wyeth Research with all regulatory study site start-up and maintenance, contract and budget negotiations, and project management for a global osteoporosis program that had 300 sites. As part of this study, Lois Rosenberger was the global project director managing a major CRO that was responsible for monitoring, data management, and statistics. 

Since 2001 (preferred provider as of 2003), LBR has provided Wyeth Research with clinical site study start-up activities. LBR has been responsible for getting sites through the pre-initiation process, regulatory document collection, and IRB approval for over 3,000 clinical sites in women’s health (osteoporosis, hot flushes, contraception), CNS (schizophrenia, depression, anxiety, Alzheimer’s), endocrine (diabetes), oncology (breast cancer) and then maintaining regulatory documents throughout the course of the trials. For other Sponsors, LBR Regulatory has been responsible for these activities in prostate cancer (50 sites), ovarian cancer (58 sites), and women’s health (400 sites).

Since 2004, a team of LBR employees has been dedicated to the conduct of the four pivotal Phase 3 studies that supported approval of the first drug for treatment of heavy menstrual bleeding (Lysteda™, November 2009) and one Phase 3 study in prostate cancer (NDA recently submitted).

In 2009, LBR completed the project management of four (2 efficacy, one safety and one rollover) Phase III HMB studies for Xanodyne Pharmaceuticals. These studies were completed six months ahead of schedule and were the basis for FDA approval of the drug (Lysteda™) in November 2009, 180 days after submission of the NDA. At the start of the clinical development plan, LBR prepared the argument that resulted in the FDA agreeing that the drug met fast track requirements. 

LBR was responsible for managing the CMC activities and writing the CMC, Non-Clinical and Overall Clinical Efficacy and Safety sections of the BLA for the smallpox vaccine developed by Acambis that was approved by the FDA. 

In addition to the BLA, LBR has written and maintained INDs for oncology projects and has been the regulatory department for multiple companies requiring US regulatory strategy and filing capabilities. 

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