Medbio Reference Laboratories

MedBio Reference Laboratories is an innovative leader in clinical and research services, accredited under the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP). Our cutting-edge clinical laboratory specializes in diagnostic assays for various medical conditions such as allergy, asthma, immunology, infectious diseases, genetic and rare diseases.

We provide central laboratory services to pharmaceutical, biotechnology, and medical device companies, supporting their clinical trial research with customized solutions. Additionally, we collaborate on the development of biomarker and companion diagnostic assays for therapeutic agents and conduct thorough analytical and clinical validation studies on In Vitro Diagnostic (IVD) products.

We provide central laboratory reference and regulatory services, acting as a contract research organization. Committed to excellence, our laboratory scientists and staff adhere strictly to CLIA standards and maintain compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) principles for clinical research.

Contract Research Organization (CRO) Services

We collaborate closely with partners from pharmaceutical companies, acting as their trusted central/reference laboratory for FDA-regulated clinical trials, including New Drug Applications (NDAs) or Investigational New Drug (IND) Applications. We work seamlessly with clinical trial sites to efficiently recruit participants, leading to successful enrollment.

Medical Device Development Services

We perform any level of verification and validation testing required for regulatory approval of In Vitro Diagnostic (IVD) devices or companion diagnostics. Our goal is to assist companies with their product development and its expedient entry into the market.

Clinical Diagnostics

Our state-of-the-art clinical laboratory has a broad and diverse array of diagnostic platforms catering to each client’s unique needs with customizable, high-complexity, and high-throughput testing solutions.