Services

• Global Market Expansion

  Market Access Strategy

  Sponsor or MAH Qualification

  Import&Export Bridge

  QP Service

  GMP Due Diligence

• Inspection Readiness

  GAP analysis

  Upgrade and Coaching

  Mock Inspection

  Inspection Guidance

  Post Inspection Support

• Facilities Validation

  Facilities Concept

  Design Drawing Review

  Qualification and Validation concept

  Commissioning and qualification Execution

  Validation Support

• Quality Management

  QMS Establishment

  QMS Optimization

  Outsourced QA Office

  Risk Management or CCS

  Statistics Application

• CS&AI Compliance

  CS Management System

  CS Validation

  IT Infra Qualification

  Data Integrity

  AI Concept and Compliance

• More Consulting

  Regulatory Briefing

  2nd or 3rd Party Audit

  Training and Workshop

  Technology Transfer

  Pharma Translation