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Regulatory/Submission-Level Document Preparation and Review
Veterinary Pathology
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Professional Toxicology Services
Services
Professional Nonclinical Services
Regulatory/Submission-Level Document Preparation and Review
Veterinary Pathology
Expertise
Toxicology Services
Veterinary Pathology
Pharmacology
Pharmacokinetics
Clients
About Us
Company Profile
Leadership
Testimonials
Contact Us
Contact Us
Services
Professional Nonclinical Services
Regulatory/Submission-Level Document Preparation and Review
Veterinary Pathology
"Grace’s experience allowed us to challenge and think through the best strategy to help address the known FDA’s concerns on our early product plan..."
ViroXis
Ian Clements, Co-founder, President & CEO
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Veterinary Pathology
Study pathologist services for non-GLP and GLP studies including carcinogenicity studies
Peer review pathologist for non-GLP, GLP studies and carcinogenicity studies at the CRO
Safety and risk assessment of novel compounds
Expertise in investigative strategies to study mechanism of disease and toxicity
Interpretation of investigative procedures including immunohistochemistry, electron microscopy and target tissue cross reactivity
Project subject matter expertise
Nonclinical study design and protocol development
Review and interpretation of nonclinical data
Review and integration of scientific literature
Preparation of nonclinical summary regulatory documents
Monitoring CRO studies to ensure compliance to study protocol and standard operating procedures