LBR PROVIDING REGULATORY, CLINICAL AND QUALITY CONSULTING SERVICES SINCE 2001

LBR was founded in 2001 by Lois B. Rosenberger, Ph.D. and Steve Rosenberger, J.D. on the belief that a team of experienced professionals, who were driven by a hands-on work ethic and unencumbered by the administrative processes of a larger company, could deliver higher-quality regulatory and clinical services in a more cost-effective manner.

Since 2001, the company has held true to this basic principle, and this dedication has been rewarded with a steady flow of repeat business from satisfied clients and subsequent referrals.

We continue to grow and now the company maintains a large client base of pharmaceutical companies of all sizes: from start-up and small companies to medium-large sized drug, device and biotech companies who lack in-house resources.

As a boutique CRO, LBR provides quality end-to-end services including a broad range of regulatory services for running and managing all aspects of clinical research trials. Tailored approaches for companies that require extended capabilities due to a shortage of in-house expertise.

This concept allows small to mid-size companies to reap the benefits associated with in-house regulatory compliance and clinical project management expertise without the long-term overhead commitments.

SENIOR MANAGEMENT

LBR’s Senior Management team participate actively in studies and assume Project Management roles, monitoring, quality assurance roles, a multi-faceted approach across studies. They are highly trained and provide direction, resolve issues and understand the FDA expectations at sites.

LBR Senior Management Team, (Back Row) Steve Rosenberger, JD – Vice president; Jeff Rosenberger, JD – Chief Operating Officer; Greg Kelso, PhD – Vice President, Regulatory Affairs, (Front Row) Cathy Johnson, BS – Director, Quality Assurance; Lois B. Rosenberger, PhD – President; and Beth Mack, PharmD – Director, Clinical Project Management.

    • 43 years of experience in the pharmaceutical industry

    • Regulatory strategic consulting, regulatory administration including FDA liaison (Drug, Biologic and Veterinary Divisions), FDA advisory committee preparation

    • Medical writing, white paper defenses for regulatory agencies, expertise in writing INDs, ANDA, NDA, NADA and briefing meeting documents

    • Regulatory and Clinical project management for US and global projects

    • 23 years of clinical quality assurance experience in site audits (US and globally), regulatory submission document auditing, Clinical study report auditing, Inspection readiness at clinical sites

    • Quality assurance, regulatory compliance and manufacturing experience in drugs and biologics

    • RX to OTC experience

    • 16 years’ experience in R&D in pharmaceutical companies and 27 years’ experience in the CRO industry

    • 27 years of pharmaceutical experience

    • Toxicology, GLP officer, nonclinical and clinical writing and regulatory submission writing, regulatory affairs, and project management

    • Writing nonclinical and clinical reports, ISS, ISE and clinical summary experience in drugs, biologics and vaccines, nonclinical INDs, briefing documents

    • 8 years’ experience in defense of drug product liability litigation involving drugs and devices

    • Providing pharmaceutical companies with advice regarding FDA regulations, patient safety issues, IRB concerns, and general product exposure issues

    • Clinical project management including site contract negotiations US and globally

    • 23 years of clinical quality assurance experience in site audits globally, regulatory submission document auditing, Clinical study report auditing, Inspection readiness at clinical sites, GLP auditing

    • 9 years of CRO experience

    • 9 years’ experience as Clinical project manager for multiple indications (Phase 1-3)

    • Management of assigned monitors and internal staff (regulatory and IRB) for clinical studies

    • Clinical site monitoring

    • Site contract and budget negotiations

    • Responsible for managing MSAs and SOWs with sponsors

    • Responsible for working with internal staff to ensure operational tasks can be accomplished

    • Business development

    • 4 years of management experience responsible for multiple departments in Property Management in Japan

    • 26 years of pharmaceutical experience

    • CMC expertise in drugs and biologics

    • Regulatory project management for CMC, nonclinical, clinical

    • Expertise in writing clinical reports, CMC sections, INDs, ANDA, NDA, INDs, INAD, BLA

    • Pre-IND, NDA, BLA Meeting Preparation

    • Authorized representative for small companies

    • 16 years’ Clinical quality assurance auditing including site audits, vendor qualification audits for central labs, analytical labs

    • 21 years of CRO experience

    • 4 years’ experience as a Clinical research associate responsible for monitoring clinical sites

    • 9 years’ experience as a Clinical project manager responsible for managing Phase 3 studies

    • 6 years’ experience as Document manager responsible for maintaining Veeva Vault and quality of all documents for clinical studies

    • 2 years as Manager of quality assurance responsible for company SOPs, training, auditing internal documents (IND sections, CSRs, Investigator Brochures) and Veeva Vault

    • Maintain internal quality control and quality assurance auditing across studies ANDA, NDA, INDs, INAD, BLA

    • 8 years’ experience in audits for sites, submission documents and eTMFs

    • 14 years of CRO experience

    • 10 years’ experience as Clinical project manager for multiple indications (Phase 1-3)

    • 4 years’ experience as Clinical research associate responsible for monitoring clinical sites

    • Experience in vendor management (central labs, IRBs) and safety manager for Phase 3 studies

    • 6 years’ experience as Document manager responsible for maintaining Veeva Vault and quality of all documents for clinical studies

    • Write safety narratives, manage and review SAE reports

    • Manage investigational product

    • Training site personnel on protocol

Our Industry-wise staff will complement your existing team.

LBR continues to grow and expand our knowledge base. We have 30 full time employees and 20 contractors who have extensive experience in drug development, clinical project management, site management, monitoring, regulatory and quality assurance activities. We match the right team with the project requirements.

Our PMs/PDs have a multifaceted background allowing for a wealth of knowledge being brought to a project and can reach out to other colleagues for advice enabling them to work through vendor issues quickly.