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D.H. Gold Associates, Inc.

Regulatory Submission Specialists

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.

Clinical 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.