LBR REGULATORY & CLINICAL CONSULTING SERVICES INC
IS A CLINICAL RESEARCH ORGANIZATION (CRO)

Specializing in Clinical Product Development, Regulatory Strategy, and Quality Assurance services for the pharmaceutical, healthcare, medical device and life sciences industries. 

For nearly a quarter century, LBR has been here to support SME and Multinationals alike to advance their products through product approval and regulatory pathways available to our clients.

We focus on getting medicines to market, so our clients can focus on improving patients’ lives.

EXPERIENCE

QUALITY

DEDICATION

INTEGRITY

LBR has addressed the needs of our Clinical and Regulatory affairs clients with industry wisdom that comes with longevity in the pharmaceutical, life science and medical device industries. Our experienced staff are specialists in their fields, from clinical researchers, pharmacologists, to legal professionals and quality assurance auditors - we have you covered.

LBR flexible approach produces bespoke solutions geared to the client, in a cost-sensitive economic environment with quality, professionalism and attention to detail. The core team have spent decades honing their skills in Regulatory, QA and Clinical Management. We look after our clients’ business as if it were our business, from concept through marketing registration and beyond, we view your success as our success.

OUR SERVICES

From concept through approval for US drug and medical device market licensing applications, LBR provides bespoke experienced Clinical Trial Design and Operational Management, Clinical Quality Assurance, and Regulatory Strategic Consulting, including dossier submission, medical writing and preparation (of, for example, FDA Briefing documents, INDs, NDAs, annual report submissions, Orphan Drug Applications, 510K (generic applications), as well as animal drugs and device applications).

AREAS OF EXPERTISE

For over 25 years we have addressed the needs of many clients at various stages of development with a wide spectrum of therapeutic expertise including:

  • Infectious Diseases, Vaccines and Phages

  • Neurosurgery

  • Osteoarthritis

  • Rare Diseases

  • Ulcerative Colitis

  • Veterinary

  • Antimicrobial / Anti-Infectives

  • Cannabinoid Addiction

  • Cancer Therapeutics

  • Diabetes & Endocrine Disorders

  • Femtech & Women’s Health

  • Pediatric

TALK TO US TODAY

Whether you are a start-up looking to begin your product licensing approval journey, a well-established industry member needing to supplement your team, an overseas company seeking an FDA Regulatory Agent, a venture capitalist or a legal professional seeking independent expertise, we may be able to assist you. Talk to us today.