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Harpaz Consulting
Services (HCS) was founded to provide regulatory
and technical expertise to manufacturers of Drug Products,
Active Pharmaceutical Ingredients "APIs",
and Medical Devices. With our extensive experience in
Dosage Form Development, Quality Assurance and Regulatory
Affairs we assist companies to comply with FDA's regulations.
HCS provides hands-on expertise in Product and Process
Development, Compliance and Validation Programs.
Through our network of contacts, we provide
expertise in pharmaceutical plant design and construction,
IND, NDA and ANDA preparation, toxicology, medical and
clinical studies.
If your business is R&D, pilot-scale,
or full-scale production in the API, pharmaceutical,
medical device, or hybrid product industries, you can
benefit from the broad experience offered by Harpaz
Consulting Services: Training,
Regulatory Compliance, Validation, Product and Process
Development
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- Evaluation of Quality Systems
- Site and Product Registration
- Internal GMP Audits
- SOP Preparation
- Analytical Laboratories Audit
- Drug Master File Preparation
- Prepare responses to 483s
- Correct Adverse Findings
- Mock Pre-Approval Inspections
- Risk Assessment of Supplies
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- Installation and Operation Qualification
- Validation Procedures
- Cleaning Validation
- Process Validation
- Prepare Validation Protocols
- Protocol Implementation
- Data Collection/Analysis
- Analytical Methods Validation
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- Scale-Up from Pilot to Production
- Process Optimization
- CMC Documentation
- Technology Transfer
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- GMP Basics
- Regulatory Compliance
- Technical/Scientific Issues
- In-house Seminars
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