top of page
iHisto GLP lab

GLP Histology Services for Preclinical Studies

iHisto provides histology support for research and regulated nonclinical programs. For projects designated as GLP, the approved scope is performed under controlled procedures with documented training, equipment and reagent records, quality assurance oversight, sample traceability, and study-specific reporting requirements.

​

Before study initiation, iHisto confirms the applicable GLP scope, protocol responsibilities, chain-of-custody requirements, data deliverables, deviation handling, archiving requirements, and sponsor expectations.

Why GLP Histology and GLP Preclinical Services Matter

In drug development, preclinical histology plays a pivotal role in evaluating the safety, efficacy, and tissue-level impact of investigational compounds. Regulatory agencies, including the FDA, require toxicology and pathology data from studies performed under Good Laboratory Practice (GLP) conditions.

​

By combining deep histology expertise with GLP standards, iHisto ensures that every tissue section, stain, and analysis is performed with full traceability and audit-readiness. This enables your data to stand up to regulatory review and support decision-making for IND submissions and beyond.

Our GLP Histology Capabilities

Our GLP Histology and Preclinical workflows support a wide range of research programs:

​

  • Safety & Toxicology Pathology – acute, sub-chronic, chronic studies; liver, kidney, immune, cardiac, and bone marrow toxicities

  • Carcinogenicity & Genotoxicity – tumor classification, genetically modified models, proliferation/apoptosis markers

  • Pharmacodynamics – oncology and fibrosis models, biomarker evaluation by IHC/IF/ISH

  • Medical Device Pathology – GLP histology evaluation of tissue response and biocompatibility

  • Biologics & Small Molecules – biomarker expression, mechanism-of-action studies

  • Reproductive Pathology – ovary, testis, uterus, placenta; GLP reproductive toxicology support

  • Wound Healing Models – fibrosis, angiogenesis, inflammatory biomarkers

  • Inhalation Toxicology – lung histology, surfactant proteins, inflammatory responses

  • Neurologic Models – CNS histology, demyelination, GFAP/NeuN/Iba1 staining

  • Digital Pathology & Peer Review – whole-slide imaging (GLP compliant), remote access, pathology peer review

​

By integrating these applications into a GLP framework, we provide clients with high-quality preclinical pathology datasets that support regulatory submissions and sponsor decision-making.

Why Choose iHisto for GLP Histology & Preclinical Studies?

  • Speed Without Compromise – Our workflows are optimized for rapid turnaround, so your studies progress without delays.

  • Expert Pathology Support – Access to GLP-trained toxicologic pathologists for expert interpretation.

  • State-of-the-Art Facilities – Advanced equipment, including Leica and 3DHISTECH platforms, for reliable results.

  • Flexible Engagement – From full GLP preclinical packages to specific histology tasks, we tailor services to your study design.

  • Audit-Ready Deliverables – Our reports and data are prepared with FDA and sponsor audit-readiness in mind, ensuring submission confidence.

Our Commitment to GLP Standards

At iHisto, compliance with Good Laboratory Practice is not optional — it is the foundation of our service.

​

  1. Standard Operating Procedures (SOPs): Every step of the histology workflow is documented, validated, and auditable.

  2. Quality Assurance (QA): Independent QA oversight ensures data integrity, report compliance, and audit readiness.

  3. Traceability: All samples, reagents, and instruments are logged to ensure reproducibility.

  4. Training: Our staff undergo continuous GLP training to meet the evolving expectations of regulators and sponsors.

  5. Confidentiality: All data are handled under strict security protocols to protect sponsor IP.

Comprehensive GLP Preclinical Histology Capabilities

iHisto provides an end-to-end platform for GLP-compliant preclinical histology services:

​

1. Tissue Processing & Embedding

  • Paraffin embedding, cryo-embedding, resin embedding

  • Optimized protocols for different organ systems and model types

​

2. Sectioning

  • Microtomy and cryotomy at research- and GLP-quality standards

  • Thin and thick sections depending on study requirements

​

3. Staining

  • H&E (Hematoxylin & Eosin) as the gold standard for toxicology and pathology review

  • Special stains for connective tissue, fibrosis, lipid, and infection models

  • Immunohistochemistry (IHC) and Immunofluorescence (IF) for biomarker detection

  • In situ hybridization (ISH) for gene expression and mechanistic studies

​

4. Pathology Support

  • GLP-trained pathologists for peer review and study interpretation

  • Tumor classification, tissue grading, and histopathology scoring

  • Reporting aligned with GLP archiving and audit requirements

​

5. Digital Pathology & Archiving

  • Whole-slide imaging (3DHISTECH scanners, 40x resolution)

  • Secure cloud-based access for sponsor review

  • Compliant data management for GLP records

Partner With iHisto for GLP Preclinical Success

Drug development is time-sensitive, resource-intensive, and heavily regulated. By partnering with iHisto, you gain a histology provider that understands the importance of GLP Histology and GLP Preclinical services in generating reliable, auditable, and regulatory-ready datasets.

​

We work with top biotech, pharma, and academic partners to deliver services that accelerate IND filings, reduce study risk, and maintain the highest standards of data integrity.

Frequently Asked Questions (FAQ)

Q1. What is GLP preclinical histology?

GLP preclinical histology refers to tissue processing, staining, and pathology conducted under Good Laboratory Practice (GLP) standards, ensuring data integrity and regulatory compliance for toxicology and pharmacology studies.

​

Q2. How does iHisto support GLP compliance?

For projects designated as GLP, iHisto follows controlled and approved SOPs, maintains documented sample and data traceability, and provides independent Quality Assurance oversight of applicable study activities. Project-specific GLP requirements, documentation, deviations, reporting, and archiving responsibilities are defined before study initiation to support compliance with applicable GLP requirements.

​

Q3. Can iHisto handle both GLP histology and preclinical toxicology studies?

Yes. iHisto provides comprehensive GLP histology and GLP preclinical services, from tissue processing and special stains to pathology reporting, covering toxicology, oncology, pharmacology, and device studies.

​

Q4. Do you provide digital pathology for GLP studies?

Yes. iHisto integrates digital pathology into GLP studies by scanning all slides at high resolution, enabling remote sponsor review, AI-ready datasets, and compliant archiving.

bottom of page