Pharmaceutical Consulting Services
Experienced in the design and execution of regulatory submission programs in North America, Europe, India, China, Korea and Japan.
Providing World-Class Consulting Services to the Pharmaceutical Industry
Contact D.H. Gold Associates, Inc. to discuss your regulatory submission needs.
D.H. Gold Associates, Inc. - Services
D.H. Gold Associates, Inc. offers a wide variety of services and consulting expertise. Our unblemished record for obtaining regulatory approval from the FDA and European agencies for our DMF, EDMF and CEP filings and for facility inspections on an initial inspection basis nets the standard for pharma industry consulting including:
- Quality Assurance Programs
- Personnel Training
- API Operations
- Oral Dosage Form Operations
- Aseptic Operations
- Facility & Systems Audits
- PAI Preparation
- Technical Transfer
- Equipment Qualification
- Process Validation
- Cleaning Validation
- Aseptic Operations
- Computer Systems Validation
- Laboratory Compliance
- Water Systems Validation
D.H. Gold Associates electronically registers firms and drug lists their products through the FDA Electronic Submissions Gateway.
D.H. Gold Associates experience in dealing with FDA and other Boards of Health can bolster your firm’s capabilities. We have the demonstrated capacity to define problems rapidly, develop and implement cost effective innovative solutions and work interactively with local management to meet global regulatory requirements.
D.H. Gold Associates has assembled several well skilled professionals to complement Dr. Gold's background. Detailed CV's of these associates are attached for your review.
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