What We Do

Pathology Experts provides you with the highest level of independent expertise in toxicologic pathology and related translational research. Our focus is on maintaining a team of highly experienced pathologists supported by the latest data capture software, globally standardized SOP’s and report formats, communications, stringent quality control requirements and customer support capabilities.

Services We Provide

  • Expert histopathology evaluations
  • External histopathology peer reviews
  • Independent histopathology assessments
  • Risk management of in vivo study findings and nonclinical development safety issues
  • Participation in sponsor advisory boards

Expert Working Panels

To support our clients in making critical compound development decisions, Pathology Experts can assemble from its global network a team of organ/system and therapeutic area experts an Expert Working Panel (EWP) to independently evaluate any potential development issue and provide opinions regarding a relationship (if any) of the test article to histopathology findings, relevance to human safety, the possibility of monitoring in the clinics and any other issue the client wishes to be addressed.

Regulatory Support

Our years of experience in the pharmaceuticals and biologics industry makes us ideal partners for addressing regulatory issues; preparation of regulatory documentation; appearances at regulatory agencies; expert report preparation; independent assessments and routine GLP- histopathology. To augment our regulatory expertise, Pathology Experts also includes in its network two expert toxicologists with decades of experience in study design, preparation of development plans and addressing regulatory issues.

Read about recommended best practices for determining, communicating, and using adverse effect data from nonclinical studies in this paper.

Scientific and Regulatory Policy Committee: Recommended (‘‘Best’’) Practices for Determining, Communicating, and Using Adverse Effect Data from Nonclinical Studies

Extend Your Resources

Pathology Experts can be your «Virtual Toxicologic Pathology Department» providing your company with additional expertise, resources and flexibility to meet your timetable with world class subject matter experts in the preclinical phase of compound and device development.

Contact us regarding our options for providing preclinical services via individual or teams of experts focussed on your compound or therapy. We can design a short or long term plan for a «virtual team» of experts that you can integrate into your development timetable and budget.

Biotherapeutics

Pathology Experts is a center of expertise for interpretation and translation of data from biotherapeutic safety assessment studies, including monoclonal antibodies, recombinant proteins, RNA and gene therapy products. We understand the importance of determining the relevance of animal data, particularly immune reactions, to human safety.

Toxicologic Neuropathology

Pathology Experts provides access to the comparative neurobiology and neuropathology knowledge and experience needed to address discovery and development questions of advanced cellular and gene therapies, biologics, medical devices, and small molecules needed to treat diseases of the nervous system.