Services offered by Gary Wolfe Toxicology, LLC:
Nonclinical Study Design and Management
Dr. Gary Wolfe is an expert in formulating drug development plans for small molecules and biologics for FDA submissions. He is able to identify, design, and implement nonclinical study programs in multiple species that are recommended for the IND or NDA submissions to the FDA. Dr. Wolfe’s 30+ years experience in industry and consulting has provided him unique insight and ability to identify the most appropriate contract research laboratories that suit client needs and his scientific expertise is applied in monitoring study conduct and reporting to ensure the highest quality standards are maintained from study inception through the submission of the final GLP-compliant report.
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Document Preparation and Review
Dr. Wolfe assists clients in the preparation and review of regulatory documents (IND, NDA, SPA, and IB), manuscripts, study reports, SOPs, MSDSs, and position papers. His expertise assures clients that these submissions are consistent and meet regulatory requirements.
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Additional Program Expertise
Dr. Wolfe is qualified to provide additional professional expertise that includes audits of reports and facilities for regulatory compliance, due diligence for compound acquisition, gap analysis for program completeness, litigation support and expert witness services, assistance with animal use documents, and reviews for conduct of animal studies.
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Identification and Coordination of Professional Experts
Dr. Wolfe’s wide network of professional contacts in industry and government allows him to put clients in contact with leading experts in fields including pathology, clinical pathology, pharmacokinetics, and analytical and bioanalytical chemistry. Dr. Wolfe identifies and manages these diverse teams of professionals for standard or specialized study needs.
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