Expert Pathology Consulting

Precision Pathology. Clinical Insight. Real-World Impact.

Expert consulting for biotech and pharma companies. Specializing in IHC assay development, diagnostic strategy, SOP writing, and digital pathology solutions.

Accelerate your biomarker programs with proven expertise and industry-leading methodologies.

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✓ FDA & CLIA Compliant
✓ Industry Proven
✓ Rapid Turnaround

Consulting Services

Comprehensive pathology consulting services for biotech, pharma, and diagnostics companies. From assay development to regulatory documentation, we support your entire biomarker development pipeline.

Histology & IHC Strategy

Protocol design, antibody validation, assay troubleshooting, and workflow optimization for FFPE and fresh samples. Expert guidance for biotech assay development programs.

Digital Pathology & AI

Whole-slide imaging, HALO workflow setup, multiplex IF panel design, and quantitative AI-powered pathology.

Biotech & Diagnostics Advisory

Biomarker strategy, diagnostic assay development, pathology review, clinical trial support, and translational insights for pharma and biotech companies.

SOP

SOP Writing & Documentation

Comprehensive Standard Operating Procedures for IHC assays, histology workflows, quality control, and regulatory compliance.

Clinical Trials

Clinical Trial Pathology Support

Biomarker analysis, histopathological evaluation, pathology review, and data interpretation for clinical trials. Support from Phase I through regulatory submission.

Regulatory

Regulatory Submission Support

FDA, CLIA, and CAP compliance guidance. Prepare regulatory documentation, validation reports, and submission packages for diagnostic assays and companion diagnostics.

Validation

Assay Validation & Transfer

Comprehensive validation study design and execution. Assay transfer between sites, analytical validation, and clinical validation support for diagnostic development.

Training

Training & Education

Customized training workshops for laboratory personnel. IHC techniques, digital pathology workflows, quality control, and best practices for biotech and pharma teams.

Expert Review

Expert Pathology Review

Second opinion consultations, pathology case review, biomarker interpretation, and expert evaluation of tissue-based assays for biotech and pharma programs.

SOP Writing Services

Expert Standard Operating Procedure (SOP) development for biotech and pharma companies. Ensure regulatory compliance, reproducibility, and quality assurance with professionally written documentation.

IHC Assay SOPs

  • ▸ Antibody validation protocols
  • ▸ Staining procedures (singleplex & multiplex)
  • ▸ Antigen retrieval methods
  • ▸ Detection system protocols
  • ▸ Counterstaining procedures
  • ▸ Quality control checkpoints

Histology Workflow SOPs

  • ▸ Tissue processing protocols
  • ▸ Embedding and sectioning procedures
  • ▸ H&E staining workflows
  • ▸ Special stain protocols
  • ▸ Slide preparation and labeling
  • ▸ Equipment maintenance procedures

Quality Control & Validation

  • ▸ QC testing procedures
  • ▸ Positive/negative control protocols
  • ▸ Assay validation documentation
  • ▸ Troubleshooting guides
  • ▸ Deviation handling procedures
  • ▸ Documentation and record keeping

Digital Pathology SOPs

  • ▸ Whole slide imaging protocols
  • ▸ Image analysis workflows
  • ▸ HALO platform procedures
  • ▸ Data management and storage
  • ▸ Image quality assessment
  • ▸ AI/ML validation protocols

Why Choose Our SOP Services?

Regulatory Compliance

SOPs written to meet FDA, CLIA, CAP, and ISO standards. Ensure your documentation supports regulatory submissions and inspections.

Industry Expertise

Deep understanding of biotech and pharma workflows. SOPs tailored to your specific assay platforms, instrumentation, and organizational needs.

Clear & Reproducible

Step-by-step procedures that ensure consistency across teams and sites. Reduce variability and improve assay reliability.

Time & Cost Efficient

Accelerate your development timeline. Avoid costly delays from inadequate documentation or regulatory feedback.

Industry Focus

Biotech Companies

Support early-stage biomarker discovery through clinical validation. Develop robust IHC assays for companion diagnostics and therapeutic development.

  • • Companion diagnostic development
  • • Biomarker validation studies
  • • Assay transfer and optimization
  • • Regulatory strategy guidance

Pharmaceutical Companies

Clinical trial pathology support, diagnostic strategy, and regulatory documentation for drug development programs.

  • • Clinical trial pathology review
  • • Diagnostic assay development
  • • Regulatory documentation
  • • CRO oversight and quality assurance

Diagnostics Companies

Assay development, validation, and regulatory submission support for in vitro diagnostic (IVD) products.

  • • IVD assay development
  • • Validation study design
  • • Regulatory submission support
  • • Quality system documentation

About PathologyEdge

PathologyEdge provides specialized consulting bridging anatomic pathology, immunohistochemistry, digital imaging, and translational science. We support biotech teams, diagnostics ventures, CROs, and research organizations in building robust assays, interpreting tissue-based data, and accelerating project timelines.

Our expertise spans the entire biomarker development pipeline—from early discovery through clinical validation and regulatory submission. We combine deep technical knowledge with practical industry experience to deliver actionable solutions that move your programs forward.

H&E stained histology slide showing tissue morphology

Pathology Resources

Curated tools, databases, and educational resources for pathology professionals, researchers, and students.

Databases & References

Digital Pathology Tools

IHC & Staining Protocols

Educational & Training

IHC-Based Companion Diagnostics

FDA-approved and clinically validated IHC companion diagnostics used in precision medicine to guide therapeutic decisions.

Oncology Companion Diagnostics
  • ▸
    HER2 (Herceptin/DM1) - Trastuzumab, T-DM1 for breast and gastric cancer
  • ▸
    PD-L1 (Keytruda/Opdivo) - Pembrolizumab, Nivolumab for multiple cancers
  • ▸
    ALK (Xalkori/Zykadia) - Crizotinib, Ceritinib for NSCLC
  • ▸
    EGFR (Erbitux/Vectibix) - Cetuximab, Panitumumab for colorectal cancer
  • ▸
    c-MET (Tabrecta) - Capmatinib for NSCLC with MET exon 14 skipping
  • ▸
    MSI/dMMR (Keytruda) - Pembrolizumab for MSI-H/dMMR solid tumors
  • ▸
    BRCA1/2 (Lynparza) - Olaparib for BRCA-mutated cancers
Additional IHC Biomarkers
  • ▸
    ER/PR (Hormone Therapy) - Tamoxifen, Aromatase inhibitors for breast cancer
  • ▸
    Ki-67 (Proliferation) - Prognostic marker for multiple cancer types
  • ▸
    BRAF V600E (Zelboraf/Tafinlar) - Vemurafenib, Dabrafenib for melanoma
  • ▸
    NTRK (Vitrakvi/Rozlytrek) - Larotrectinib, Entrectinib for NTRK fusion cancers
  • ▸
    TMB (Tumor Mutational Burden) - Predictive biomarker for immunotherapy
  • ▸
    CD19/CD20 (Rituxan) - Rituximab for B-cell lymphomas
  • ▸
    CD30 (Adcetris) - Brentuximab vedotin for Hodgkin lymphoma

Note: This list includes FDA-approved and clinically validated IHC-based companion diagnostics. Biomarker testing requirements may vary by indication and therapeutic agent.

Quick Reference Links

Biomarker Databases
Protocol Repositories
Clinical Trials
Image Analysis

Pathology Vendors

Comprehensive directory of vendors for antibodies, microscopes, digital slide scanners, and human tissue FFPE blocks.

Antibodies & IHC Reagents
Microscopes
  • Olympus - Light and fluorescence microscopes
  • Leica Microsystems - Light, confocal, and digital microscopes
  • Zeiss - Light, confocal, and electron microscopes
  • Nikon - Research and clinical microscopes
  • Motic - Digital and compound microscopes
  • Keyence - Digital microscopes and imaging
Digital Slide Scanners
Human Tissues & FFPE Blocks

Contact

For consulting inquiries, collaborations, or project discussions, reach out below.

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