REGULATORY AFFAIRS
 
    CGMP Audits of manufacturing and QC laboratory facilities
    Plan and perform mock audits to prepare for Pre-approval Inspections
    Regulatory gap analysis audits which compare approved market authorization commitments
    to actual practices in your manufacturing operations
    Information Technology audits to establish regulatory boundaries and assess the level of
    regulatory compliance

 
 
  DOCUMENTATION PREPARATION
 
 
    Validation and Regulatory Consulting
    Validation Master Plan (VMP)
    Design Review
    Vendor Evaluations
    Acceptance Testing Protocols (Factory & Site)
    Installation, Operational, Performance Qualification Protocols and Reports
    Standard Operating Procedures (SOP)
    Turn-Over Packages
    Quality Internal Audits
    Functional Requirements / Specification