Veterinary Clinical Pathology · Consulting

Precision
Pathology
Expertise

Translational and toxicologic clinical pathology consulting for pharmaceutical development, CRO partnerships, and environmental health assessment.

Credentials DVM, MS, Dipl. ACVP (Clinical Pathology)
Training Cornell University and University of Florida
Company URIKA, LLC — Langley, WA
Services Clinical pathology for Academic · CRO · Biotech · Large Pharma
Leadership ASVCP Treasurer; Quality Assurance and Laboratory Standards Previous Chair and Guidelines Author
Contact drharr@urikapathology.com
79+
Publications
8K+
Citations
25+
Yrs Experience
Preclinical Toxicology GLP Study Support Regulatory Compliance IND/NDA Data Interpretation Reference Interval Development Assay Validation Environmental Health Assessment Biomarker Evaluation Expert Review & Testimony Preclinical Toxicology GLP Study Support Regulatory Compliance IND/NDA Data Interpretation Reference Interval Development Assay Validation Environmental Health Assessment Biomarker Evaluation Expert Review & Testimony

Areas of Practice

Specialized consulting at the intersection of clinical pathology and drug development

Dr. Harr brings board-certified veterinary clinical pathology expertise to clients requiring rigorous data interpretation, regulatory-grade documentation, and translational insights across species and study types.

01
Preclinical & Translational Pathology

Clinical pathology support for IND-enabling and GLP toxicology studies across pharmaceutical and biotechnology programs.

  • Hematology & clinical chemistry interpretation
  • Urinalysis and coagulation evaluation
  • Peer review of study data packages
  • IND, NDA, and BLA data interpretation
  • Cross-species translational analysis
02
Environmental Toxicology & Health Assessment

Clinical pathology evaluation of free-ranging and managed wildlife populations exposed to environmental contaminants and stressors.

  • Population-based reference interval development
  • Contaminant exposure biomarker assessment
  • Field sample quality evaluation and interpretation
  • Regulatory agency liaison support
03
Laboratory Quality & Assay Validation

Design, validation, and quality oversight of diagnostic assays and laboratory programs in compliance with ASVCP guidelines and GLP requirements.

  • ASVCP QA guideline implementation
  • Point-of-care & reference lab evaluation
  • Laboratory design, build-out, and implementation
  • Sigma metrics & error tolerance
  • New assay validation design
  • Instrument performance assessment
04
Expert Consultation & Review

Independent expert review, scientific advisory support, and expert witness testimony for legal, regulatory, and investigative matters.

  • Independent pathology data review
  • Scientific advisory board participation
  • Expert witness and litigation support
  • Publication and manuscript review
  • Continuing education & training
05
Zoological & Exotic Species Pathology

Diagnostic expertise in non-domestic species with particular depth in reptiles, amphibians, avian species, and marine mammals.

  • Wildlife and zoological population health monitoring
  • Bone marrow evaluation — exotic species

Pharmaceutical & CRO Services

A dedicated clinical pathology partner across the drug development continuum

From discovery through regulatory submission, Dr. Harr provides the board-certified oversight that CROs, biotech firms, and large pharmaceutical companies require to meet the highest standards of data quality and regulatory defensibility.

Services for Drug Development & CRO Partners

CP
Clinical Pathology Study Support

GLP and non-GLP toxicology study design, monitoring, and data interpretation for IND-enabling programs across rodent and non-rodent species.

RI
Reference Interval Development

De novo reference interval generation following ASVCP guidelines, including statistical analysis and species-specific considerations.

AV
Assay Validation & Fit-for-Purpose Testing

Novel biomarker and clinical chemistry assay validation, including precision, accuracy, and cross-platform comparability assessments.

PR
Peer Review & Expert Signatory

Independent review of clinical pathology data packages, report sign-off, and regulatory submission support for FDA and international agencies.

TR
Translational Biomarker Strategy

Cross-species translational analysis linking preclinical pathology findings to clinical safety monitoring endpoints and patient risk assessment.

"Kendal's clinical pathology expertise would be an asset to any group. She has a large breadth of experience from academic, CRO, small biotech and large pharmaceutical companies."

— LinkedIn Recommendation, URIKA LLC

Dr. Harr has contributed directly to the regulatory guidance landscape as a member of the ASVCP Regulatory Affairs Committee, authoring best practice recommendations for veterinary toxicologic clinical pathology in pharmaceutical and biotechnology industries.

— Regulatory Background

Regulatory Familiarity

FDA GLP 21 CFR 58
ICH S7A / S7B
OECD TG 407/408
ASVCP RAC Guidelines
EMA Guidance
SEND / ECTD

About

Kendal E. Harr,

DVM, MS, Dipl. ACVP (Clinical) · Owner & Senior Pathologist, URIKA, LLC

Dr. Kendal Harr is a board-certified veterinary clinical pathologist with more than 25 years of experience spanning academic medicine, contract research organizations, and pharmaceutical and biotechnology consulting. She founded URIKA, LLC to provide independent, high-caliber clinical pathology services to clients who require expertise that goes beyond routine diagnostic support. Resume or CV available upon request.

Dr. Harr has been a consistent contributor to key texts and the guidelines that govern quality in veterinary clinical pathology. She co-authored the ASVCP allowable total error guidelines for biochemistry, the ASVCP reference interval guidelines, and multiple quality assurance frameworks now used by veterinary laboratories worldwide. Her work on regulatory best practices for toxicologic clinical pathology in pharmaceutical settings reflects the same commitment to defensible, reproducible science.

With more than 8,000 citations and 79 peer-reviewed publications and book chapters, Dr. Harr brings both scholarly depth and practical industry experience to every engagement. She has collaborated with clients ranging from small biotechs to global pharmaceutical corporations, and brings the same rigor and personal attention to each.

View Publication Record on Google Scholar →

Credentials

DVM, MS, Dipl. ACVP (Clinical Pathology)

Training

Cornell University
University of Florida

Leadership

ASVCP Treasurer
QA & Lab Standards Chair (prev.)
Guidelines Author

Publications

79+ peer-reviewed publications & book chapters

Citations

8,000+

Experience

25+ years

Species Expertise

Cross-species diagnostic capability

Effective translational pathology requires genuine expertise across the species used in research — not just rodents. Dr. Harr's diagnostic experience spans standard toxicology models and non-traditional research and wildlife species.

🐭
Rodents
Rat · Mouse
🐕
Canine
Domestic & Research
🐒
Primate
NHP Models
🐊
Reptiles
Snakes · Lizards · Turtles
🐸
Amphibians
Anurans · Caudates
🐦
Avian
Wild & Domestic
🐋
Marine Mammals
Manatee · Cetaceans
🐱
Feline
Domestic · Exotic
🐟
Aquatic Species
Fish & Invertebrates
🐰
Rabbit
Research Models
🐖
Swine
Minipig · Farm
🦎
Exotic / Zoo
Wildlife Species

Get in Touch

Bring expert pathology to your next project

Whether you are scoping a GLP toxicology study, need independent data review, or are developing a quality program for your laboratory, Dr. Harr welcomes direct inquiries from clients from diverse backgrounds.

Email

drharr@urikapathology.com

Location

Washington, USA

Availability

Consulting engagements · Expert review · Advisory roles

Project Inquiry