February 23, 2024
BTS Research Completes Corrections of FDA 483 Observations From the desk of the President & CEO On July 8, 2022, U.S. Food and Drug Administration (FDA) Investigator concluded an inspection of the BTS Research facilities located in San Diego, CA and issued Inspectional Observations on the form FDA-483 that triggered a Warning Letter issued on Oct 20. 2023. The observations were mainly due to intermittent Study Director review of data, old equipment, and inspections frequency. BTS Research reported the completion of these observations on Nov 8th, 2023, to the FDA. These corrections triggered a more consistent Study Director review of...
April 30, 2020
BTS Research is taking in animals for temporary housing from local vivariums BTS provides services in the following research animals: Rodents. Rabbits. Guinea pigs. Dogs NHP's. Contact us for more details.
January 22, 2020
BTS Research is pleased to share with its clients the results of the FDA audit which was concluded on December 4th, 2019. Following a 14-day onsite inspection, the FDA concluded their inspection of a 2-week GLP Rat Intravenous study and a 26-Week GLP Oral dog study for two of BTS’ clients. The FDA affirmed that the studies have been performed under the Good Laboratory Practice for Nonclinical Studies regulations [Title 21, Code of Federal Regulations, Part 58]. “We are very pleased with the inspection results especially that the inspection came at a time when BTS Research was in the middle...
December 28, 2018
BTS Research is finishing 2018 on a high note BTS Research is pleased to report this year's USDA inspection has been completed with 0 findings. Since BTS incubation in 2001, aside from minor recommendations from USDA that were addressed immediately, BTS enjoys a clean track record with all regulating agencies with no violations. Site 002 Official Report Site 003 Official Report
December 3, 2018
BTS Research has partnered with BioLaurus Inc. , an advanced molecular imaging group to bring new research capabilities to our pharma research clients. The gold standard for pre-clinical research has long been the non human primate (NHP) but access to NHP and advanced research capabilities has become ever more challenging. To meet this challenge there are two prerequisites ; the first requirement is a world class facility and staff and the second requirement is advanced molecular imaging capabilities and expertise in imaging and analysis. Molecular imaging offers unique benefits most important of which is in vivo whole animal PK/PD. Other...
November 27, 2018
With many cities and states now approving cannabis products, and without a doctor note, the American population at large is being invited to be a part of an uncontrolled drug influence clinical trial without a sufficiently regulated method to question the right dose determination hence consumers and non-consumers are subjected to possible danger. Now that the cannabis is much more widely dealt with and accepted, many new industries are forging their way with little guidance from the Federal agency regarding how to handle a substance that is well known to be toxic and addictive to be allowed in the industry...
November 19, 2018
SAN DIEGO--(BUSINESS WIRE)--BTS Research, a preclinical services Contract Research Organization, is delighted to announce the addition of Mark T. Crane as Vice President of Business Development. Mark will be taking on the Company’s Marketing, Sales, and Business Development efforts pushing BTS’s business growth model and fostering positive relationships with new and current clients. Particularly, Mark will be pushing BTS’s Toxicology capabilities that aid in the regulatory approval of clients’ drug developmental programs including GLP studies. “Mark’s combination of industry knowledge, sales training and management skills will enable BTS to move to the next level in size, scope and market leadership” Tweet this...
October 2, 2018
BTS Research is not only one of the leading CRO pharma companies in San Diego, but also a front runner in global research. BTS Research offers its clients that are looking to hire research pharmaceutical companies in Southern California exceptional services in pharmaceutical/bio pharmaceutical, biotech, academic research, medical device development, and other related industries. BTS Research, one of the major pharmaceutical companies in Southern California and a leading San Diego pharmaceutical CRO that provides customers with biomedical research and toxicology research needs. BTS Research is customer focused and derives its success through dedicated employees, integrity, quality, and strategic partnerships with industry...
See why our clients trust us to support their IND & IDE submissions
- GLP, IND-enabling studies
- Huge portfolio of species and models, including NHP, for maximum translational relevance
- "Extra mile” service and support
- Extensive bioanalytical capabilities
- Rapid study initiation - usually 2 weeks or less!