Schafer Veterinary Consultants, LLC
Worldwide consulting services since 1986.
Schafer Veterinary Consultants offers
consulting services for process and
equipment validation, equipment
cleaning validation, process
manufacturing and packaging, product
analysis and method validation, sterility
and stability testing, quality control, master production records, Good Manufacturing Practice (GMP) compliance,1 site inspections, and standard operating procedures.
Our staff is qualified and seasoned in the application of GMP regulations, the development of drug master files, the review of product labels, and the technical preparation of regulatory submissions.
Schafer Veterinary Consultants routinely participates in review, preparation, and submission of the chemistry, manufacturing, and controls (CMC) section of New Animal Drug Applications (NADAs) and Abbreviated NADAs. We are also involved in USDA establishment requirements and the development of Outlines of Production for biologics.
1 U.S. Code of Federal Regulations, Title 21, Part 211.