Facilities Design Expertise

Image Representing DHG Associates, Inc. Pharmaceutical Operations experience

 

Pharmaceutical Manufacturing Experience

Image Representing DHG Associates, Inc. Pharmaceutical Manufacturing experience

 

Proven Regulatory Compliance Results

image representing proven regulatory compliance results

 

 

 

Consultants to the Pharmaceutical Industry

 

D. H. Gold Associates, Inc. is a New Jersey headquartered company led by Daniel H. Gold, Ph.D., former Sr. Director, Quality Services for Lederle Labs and more recently Vice President Quality Assurance for Par Pharmaceutical. Based upon their hands-on, multifaceted experience skills, DHG Associates provides a broad range of technical and regulatory services to the pharmaceutical industry. The comprehensive experience base of the DHG Associates team encompasses active drug substances, biologics, oral, topical and parenteral dosage forms as well as biologics.

 

 

Regulatory Submission Expertise

 

D.H. Gold Associates, Inc.has been structured to provide technical and regulatory support to the pharmaceutical and biotechnology industries.  DHG Associates has substantial experience with active drug substances, clinical supplies, oral and topical dosage forms, as well as small volume parenterals for both human and animal health care.  DHG Associates have successfully guided the design of facilities and the execution of programs in North America, Europe, India, China, Korea and Japan.   D.H. Gold Associates, Inc. also prepare and maintain DMF, EDMF, NDA, ANDA filings and serve as US Agent for offshore companies.

 

 

 

 

 

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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

Norah M. Lightowler, BPharm, LLB, MRPharmS, FTOPRA - Senior Consultant

 

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

 

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