Quality Assurance

A comprehensive range of compliance services are offered by IPA Consulting Services to the pharmaceutical, biotechnology, API, dietary supplement, and medical device Industries. Our Compliance team is comprised of an association of highly skilled consultants drawn from former high-level regulatory officials and the Industry experts provide a wide range of mission-critical services.

They work with our clients to design and implement effective and efficient business processes that assure sustainable compliance based on the optimal integration of scientific, technical and regulatory principles.

We assist our clients to stay current with the ever-changing regulatory and technical environment and evolving industry practices. Our services relate to a broad range of products, including:

• Human Drug Products
• Veterinary Drug Products
• Biologics and Biotechnology-Derived Products
• Active Pharmaceutical Ingredients, Intermediates; Starting/Raw Materials
• Cosmetics
• Natural Health Products
• Medical Devices

Our full-service offering includes:

• Quality System Development
  
• Quality Improvement Initiatives
  
• Mock Pre-Approval Inspectional
  
• On-site Support During Inspections by Regulatory Officials
  
• GMP Audit (APIs and Finished Drug Products)
  
• Third Part Audit
  
• GMP Gap Analysis
  
• Failure and Nonconformance Investigation
  
• CAPA (Development; Execution; Monitoring)
  
• Implementation of Change Control Systems
  
• Vendor Qualification
  
• SOP and Quality Manual Preparation
  
• Protocol and Report Preparation
  
• Batch Record Review and Approval
  
• Due Diligence
  
• FDA 483 Inspection and Warning Letter Responses
  
• Interim Operational and Management Support
  
• Complaint and Recall Handling
  
• GXP Training