CBSET
CBSET is a Boston-area translational research organization that provides integrated preclinical research, testing and regulatory support for medical devices, pharmaceuticals, diagnostics and advanced therapeutics. Services include in vivo GLP and non-GLP studies, histopathology and image analysis, computational modeling, specialized model development, and regulatory strategy for FDA and global submissions.
Industries
Nr. of Employees
medium (51-250)
Products
GLP Preclinical Services
Preclinical research services that comply with Good Laboratory Practice (GLP) standards, including safety and efficacy studies for regulatory submissions.
Localized / Targeted Drug Delivery
Research and development of drug delivery systems that target specific areas of the body to improve therapeutic outcomes.
GLP Histopathology and Morphometry
Histopathological and morphometric analysis services under GLP compliance, including tissue processing, staining, and imaging.
GLP Preclinical Services for Auditory Safety
Preclinical studies focused on evaluating the auditory safety of potential therapeutics, ensuring they do not cause ototoxicity.
Medical Device Testing
Evaluation of medical devices from early iteration to large-scale GLP safety assessments, including efficacy and safety profiling of implanted devices.
Drug & Cell-based Therapies
Support for preclinical research of drug and cell-based therapies, including efficacy, safety, and regulatory strategy development.
GLP Preclinical Services
Preclinical research services that comply with Good Laboratory Practice (GLP) standards, including safety and efficacy studies for regulatory submissions.
Localized / Targeted Drug Delivery
Research and development of drug delivery systems that target specific areas of the body to improve therapeutic outcomes.
GLP Histopathology and Morphometry
Histopathological and morphometric analysis services under GLP compliance, including tissue processing, staining, and imaging.
GLP Preclinical Services for Auditory Safety
Preclinical studies focused on evaluating the auditory safety of potential therapeutics, ensuring they do not cause ototoxicity.
Medical Device Testing
Evaluation of medical devices from early iteration to large-scale GLP safety assessments, including efficacy and safety profiling of implanted devices.
Drug & Cell-based Therapies
Support for preclinical research of drug and cell-based therapies, including efficacy, safety, and regulatory strategy development.
Services
Study design and execution for safety and efficacy across therapeutic modalities under GLP or non-GLP conditions.
GLP histology workflows, slide review, quantitative histomorphometry and pathology interpretation to support preclinical programs.
Creation and validation of in vivo and ex vivo models to evaluate implantation techniques, drug kinetics and safety endpoints.
Scientific and regulatory consulting to align preclinical programs with requirements for FDA and international regulatory submissions.
In vitro, ex vivo and in vivo assays and models for auditory safety and efficacy assessment.
Training programs and procedural education for clinicians to support device introduction and clinical workflows.
Study design and execution for safety and efficacy across therapeutic modalities under GLP or non-GLP conditions.
GLP histology workflows, slide review, quantitative histomorphometry and pathology interpretation to support preclinical programs.
Creation and validation of in vivo and ex vivo models to evaluate implantation techniques, drug kinetics and safety endpoints.
Scientific and regulatory consulting to align preclinical programs with requirements for FDA and international regulatory submissions.
In vitro, ex vivo and in vivo assays and models for auditory safety and efficacy assessment.
Training programs and procedural education for clinicians to support device introduction and clinical workflows.
Expertise Areas
- Translational preclinical research
- Preclinical safety and efficacy testing (GLP and non-GLP)
- Histopathology and histomorphometry
- Medical device testing
Key Technologies
- GLP-compliant study conduct
- In vivo large-animal models (e.g., minipig models)
- Clinical-grade imaging
- Histopathology and quantitative histomorphometry
News & Updates
Press release announcing a majority growth investment and planned capacity expansion to scale CBSET's integrated preclinical research and testing platform.
Article on translational development considerations for gene therapy applied to hearing loss.
Blog post discussing the use of minipig models in drug development and translational relevance.
Article on development and application of in vitro and ex vivo models to assess ototoxicity.
Press release announcing a majority growth investment and planned capacity expansion to scale CBSET's integrated preclinical research and testing platform.
Article on translational development considerations for gene therapy applied to hearing loss.
Blog post discussing the use of minipig models in drug development and translational relevance.
Article on development and application of in vitro and ex vivo models to assess ototoxicity.