Services

Auditing Services

  • GMP Compliance Audits
  • GLP Compliance Audits
  • Due Diligence
  • Deficiency Resolution
  • Gap Analysis Audits
  • Mock Pre-Approval Inspection
  • Supplier Audits

Quality Management Systems

  • Quality Manual
  • Change Control
  • Deviations
  • Investigations
  • CAPA
  • Internal Audits


Training

  • Good Manufacturing Practices
  • Good Laboratory Practices
  • Audit Conduct
  • Supplier Qualification Programs
  • All courses can be instructor lead or webinar

Supply Chain

  • Development of Quality Agreements
  • Design of Supplier Quality Management Programs
  • Audits of supply chain including API, excipients, container/closure provider, CMOs, contract testing facilities, GLP providers

Manufacturing

  • Process Validation
  • Cleaning Validation
  • Equipment Qualification and Validation
  • Manufacturing Batch Records
  • Packaging Batch Records
  • Technology Transfer

Analytical

  • Analytical Support for Cleaning Validation
  • Analytical Equipment Qualification and Validation
  • Laboratory Controls
  • Analytical Method Validation
  • Anaytical Method Transfer
  • Raw Material Testing and Controls
  • Stability


Additional Services

Technical Writing Assistance

  • Support in writing of qualification/validation protocols/reports
  • Support in writing of manufacturing and testing documentation 
  • Support in submission writing

Project Management

Quality Support

  • Provide additional support in the review of batch records
  • Provide additional support in the review of test reports and associated data
  • Provide support in the review of submission files and source data