What is the First Step in Addressing a 483 Warning Letter?

image representing a 483 Warning Letter

Contact D.H. Gold Associates for proven expertise in 483 Recovery.

 

 

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image of pharmaceutical consultant in laboratory

 

 

 

D. H. Gold Associates, Inc. - 483-Recovery

 

483 Recovery Services

 

483 Warning Letter…. We can help your firm recover with confidence!

 

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D.H.Gold Associates, Inc. - Consultants

D.H.Gold Associates, Inc. has assembled well skilled professionals to complement Dr. Gold’s background.  Detailed CV’s of each associates are available by following the links below:

 

Daniel H. Gold, Ph.D. - President & CEO

Stanley Alekman, Ph.D. - Analytical Chemistry & Statistics Specialist

William Bennett, M.S., B.S. - Engineering & Manufacturing Specialist

Bao-Shan Huang, Ph.D. - Process Development, Analytical Laboratory Control Specialist

Jeanne Moldenhauer, M.S. - Microbiology Specialist

Eugene Rynkowski, M.S. - Analytical Chemistry Specialist

Eric Sheinin, Ph.D. - Specialist in CMC Sections of NDA, ANDA & DMF Filings

James D. Shaver, B.S., B.Ch.E - Engineering & Operational Management Specialist

Bernd Dölle, Ph.D. - Aseptic Manufacturing, PDA/FDA, Barrier Technology Specialist

Takeo Murakawa, Ph.D. - Drug Development & Regulatory Affairs Specialist

Thomas Murphy, M.S. - Industrial Statistical Consultant

 

DHG Consulting Team with a total of 195+ years in the Pharmaceutical Industry.

 

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