Services

• Global Compliance

  GMP Consultancy

  GAP Analysis

  Mock Inspection

  GMP Training

  GMP Inspection Support

  3^rd Party Audit

  QP Inspection

  Inspection Support

• Facilities Compliance

  Commission & Qualification

  Design Review

  Validation System Establishment

  Project & Process URS

  Risk Management / Risk Analysis

  Validation Master Plan

  Facilities & Equipment Qualification

  Processes Validation

• Computerized System

  CS Management System

  CSV Computerized System Validation

  Software Validation

  Infrastructure Platform

  Data Integrity (DI)

  CS Compliance Audit

  CS Compliance Training

• Plant QMS

  Structure Concept

  QMS Establishment

  Compliance Review

  Continuous Monitoring

  QMS Upgrade

  Risk Management

  Statistics Application

  Routine quality Consulting

  CCS Support

• Multination MAH/MAA

  Strategy Consulting

  MAH/MAA QMS

  License Application and Inspection

  Outsourced QA

  Vendor/Supplier Management

  GxP -GMP/GVP/GDP…