Schafer Veterinary Consultants, LLC

Worldwide consulting services since 1986.

Product manufacturing

 

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.

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¹  U.S. Code of Federal Regulations, Title 21, Part 211.