With Over 195 Years of Combined Pharmaceutical Industry Experience
D.H. Gold Associates, Inc. Has the Experience to Deliver.
Experienced in new drug development ...
... from initial filing through manufacturing design ...
... to scaling manufacturing operations.
Why Choose D.H. Gold Associates, Inc.?
DHG Associates has extensive experience in the areas of facility design and qualification, process transfer, process computer systems and cleaning validation, aseptic processing, PAI preparation, quality assurance systems, preparation of clinical supplies, laboratory management systems and employee certification programs. Facility and systems audits are a particular specialty. DHG Associates also has alliances with a network of other highly qualified organizations for the execution of larger projects. Examples of the wide range and scope of projects all executed on time and within budget.
As a result of frequent lectures and course presentations DHG Associates is well known and highly respected by regulatory agencies and pharma industry groups. Dr. Gold has a long-standing relationship with FDA as an industry expert, teaches regularly at FDA’s ORA U for Investigator Training, and has also been recruited as a member of the FDA Pharmaceutical Sciences Advisory Subcommittee on Manufacturing, the Committee formed several years ago to advise FDA on risk based initiatives for altering CGMP requirements.
As you will see from the DHG Success Stories, we have a perfect track record of securing FDA approval on a first inspection basis. Perhaps of equal significance, all of our clients who have been audited by multi-national pharma firms were found fully acceptable on a first inspection basis as well.
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