topleft
 
GMP Compliance Consultation for Pharmaceutical Industries Worldwide
Consultation for Pharmaceutical,Chemical and Medical Device Industries Worlwide
dash
 
Home
About Us
Schedule
Contact Us

GMP compliance consultant

GMP Compliance Expertise for Pharmaceutical Industries Worldwide

 

With our extensive experience in Dosage Form Development, Quality Assurance and Regulatory Affairs we assist companies to comply with FDA's regulations

  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

compliance validation
  • 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
  • Installation and Operation Qualification
  • Validation Procedures
  • Cleaning Validation
  • Process Validation
  • Prepare Validation Protocols
  • Protocol Implementation
  • Data Collection/Analysis
  • Analytical Methods Validation
process development GMP training
  • Scale-Up from Pilot to Production
  • Process Optimization
  • CMC Documentation
  • Technology Transfer
  • GMP Basics
  • Regulatory Compliance
  • Technical/Scientific Issues
  • In-house Seminars
 
lblu
rblu
 
lgry rgry

Premier Web Design Firm

 
 
topright
   
bottom left bottom%20right