Schafer Veterinary Consultants, LLC
Worldwide consulting services since 1986.
We consult in the conduct of safety and efficacy
studies for companion and food animals, including
facility and investigator sourcing, negotiation and
contracts; Freedom of Information and literature searches;
study design, protocol development and forms design;
study monitoring; quality assurance; bioanalytics and method validation;
data auditing and statistical analysis; scientific reporting; and regulatory compliance and site inspection.
Schafer Veterinary Consultants is experienced with a variety of studies, including target animal safety, human food safety (tissue residue, metabolism), and efficacy (bioavailability, pharmacokinetics, bioequivalence, dosage characterization, and field trials).
We prepare highly technical protocols and data form sets for review by the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA), and the Center for Veterinary Biologics within the U.S. Department of Agriculture (USDA). We interact with the regulatory agency to finalize study-related documents, and we contract the studies to qualified testing facilities or clinical investigators.
We are trained in the application of quality assurance methods in efficacy and safety studies conducted under Good Laboratory Practice1 (GLP) and in field studies under Good Clinical Practices2 (GCP). Our staff routinely conducts GLP/GCP qualification inspections of candidate facilities, study directors, and investigators. Schafer Veterinary Consultants regularly monitors, reviews, and audits a spectrum of efficacy and safety studies for regulatory submission.
Schafer Veterinary Consultants interacts with testing facilities and clinics where the actual studies are conducted. Our personnel have considerable hands-on experience in the conduct and management of various in vivo and in vitro studies. We serve in various capacities as a contract research organization,3 but as a consulting company, Schafer Veterinary Consultants does not own research animals and does not own or operate animal testing facilities or laboratories.
1 U.S. Code of Federal Regulations, Title 21, Part 58.
2 International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), June 2000, FDA Guidance No. 85, May 2001).
3 U.S. Code of Federal Regulations, Title 21, Part 511, Section 511.1(f)).