Pathology Services

Adgyl has an outstanding team of pathologists with over 30+ years of pathology services across both pharmaceuticals and agrochemicals. Our work has been successfully peer-reviewed multiple times by board certified pathologists from US, Europe and Japan.

Also offer standalone Pathology Services for the in-life phase of the studies conducted elsewhere. The formalin preserved wet tissues or paraffin embedded tissue blocks supplied by the client may be processed at our facility. The tissue slides may be evaluated and a comprehensive pathology report generated for submission through online data capture system.

  • Immunohistochemistry
    • Immunohistochemistry (IHC) combines anatomical, immunological and biochemical techniques to identify discrete tissue components by the interaction of target antigens with specific antibodies tagged with a visible label
    • IHC makes it possible to visualize the distribution and localization of specific cellular components within cells and in the proper tissue context
  • Neuropathology
    • To identify neurotoxic potential of new chemical entities
    • To evaluate neurotoxicity potential of agrochemical and environmental chemicals
  • Quantitative Bone Marrow Evaluation
    • To assess toxicant-induced bone marrow effects of test articles
    • In non-clinical toxicity studies, complete blood count data in conjunction with the histological examination of the bone marrow are recommended as the foundation for assessing the effect of test articles on the hematopoietic system
    • Also offer cytological evaluations of the bone marrow

Standard for Exchange of Nonclinical Data (SEND) Succeeding with SEND requirements for IND, NDA and ANDA data

SEND is an electronic formatting requirement for submission of study data contained in certain Investigational New Drug (IND), New Drug Application (NDA), Abbreviated NDA application (ANDA), and Biologic License Applications (BLA) to the US FDA. Adgyl use SubmitTM platform, suite of integrated tools and services for creation and management of SEND datasets.

We ensure that data sets are:

  • Consistent with the Study Reports
  • Validated and loadable into Nonclinical Information Management System (NIMS) without getting Refusal to File (RTF) from the FDA
  • Reviewed by the scientists to enable accurate interpretation and timely response to any questions