About Us
Principal: J. Fred Pruden, Sr.
During Mr. Pruden's thirty-five (35) year career in the pharmaceutical industry, he has directed all
facets of pharmaceutical manufacturing and packaging, QA compliance, business development, QC,
engineering, supply chain management, and other manufacturing functional departments. Mr. Pruden
has the proven ability to assess operations and provide systems and procedures to maximize
effectiveness and productivity. He has served as a consultant providing manufacturing, validation,
engineering, supply chain management, business analysis, and business development consulting
services to pharmaceutical manufacturing companies since 1998. Prior to consulting, Mr. Pruden
served as Vice President of Manufacturing Operations at AAI Pharma. At AAI Pharma, he had P&L
responsibility for sterile and solid dosage manufacturing operations, management of customer
projects for drug development and contract manufacturing of commercial and clinical supplies. He
was also responsible for technical transfers of acquired products from OEM manufacturers and R&D
projects to either in-house facilities or suitable outside contract manufacturing facilities. Previously, Mr.
Pruden was VP of Manufacturing Operations at King Pharmaceuticals, General Manager at Novo
Nordisk, Executive VP at Lyphomed and Plant Manager of Sterling Drugs' 250,000 sq. ft. sterile
manufacturing and lyophilization facility in Kansas. During his career, Mr. Pruden has been heavily
involved in all aspects of sterile fill, solid dosage form, semi solid ointments & creams and liquid fill
manufacturing operations as well as a contributor to numerous CMC sections for ANDA and NDAs.
Mr. Pruden began his career at Abbott Laboratories as a Production Manager. He earned a
Batchelor's degree in Mathematics from the University of North Carolina at Chapel Hill and has
received numerous awards for his contributions to efficiency, compliance and productivity.
During Mr. Pruden's thirty-five (35) year career in the pharmaceutical industry, he has directed all
facets of pharmaceutical manufacturing and packaging, QA compliance, business development, QC,
engineering, supply chain management, and other manufacturing functional departments. Mr. Pruden
has the proven ability to assess operations and provide systems and procedures to maximize
effectiveness and productivity. He has served as a consultant providing manufacturing, validation,
engineering, supply chain management, business analysis, and business development consulting
services to pharmaceutical manufacturing companies since 1998. Prior to consulting, Mr. Pruden
served as Vice President of Manufacturing Operations at AAI Pharma. At AAI Pharma, he had P&L
responsibility for sterile and solid dosage manufacturing operations, management of customer
projects for drug development and contract manufacturing of commercial and clinical supplies. He
was also responsible for technical transfers of acquired products from OEM manufacturers and R&D
projects to either in-house facilities or suitable outside contract manufacturing facilities. Previously, Mr.
Pruden was VP of Manufacturing Operations at King Pharmaceuticals, General Manager at Novo
Nordisk, Executive VP at Lyphomed and Plant Manager of Sterling Drugs' 250,000 sq. ft. sterile
manufacturing and lyophilization facility in Kansas. During his career, Mr. Pruden has been heavily
involved in all aspects of sterile fill, solid dosage form, semi solid ointments & creams and liquid fill
manufacturing operations as well as a contributor to numerous CMC sections for ANDA and NDAs.
Mr. Pruden began his career at Abbott Laboratories as a Production Manager. He earned a
Batchelor's degree in Mathematics from the University of North Carolina at Chapel Hill and has
received numerous awards for his contributions to efficiency, compliance and productivity.
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| CLIENTS SERVED Horizon Therapeutics Pennatek Otsuka Novavax Horizon Medical Products King Pharmaceuticals EMTRx, Ben Venue Laboratories Loch Pharmaceuticals Oakwood Laboratories Aseptica Campbell University's Pharmaceutical Sciences Institute Zor Pharmaceuticals Slate Pharmaceuticals |
| PEI CONSULTING SERVICES |
