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Annual Consulting
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Domestic & Overseas Regulatory Consultation & Interpretation
On-site Coaching
Mock Audit
Domestic & Overseas Regulatory Training
Corporate Compliance Consultancy
Global Market Access Route Planning for Products
Process Validation Optimization Advice

Corporate Compliance Consultancy

Assistance in Establishing or Improving Quality Management System Documents
  • Four-level system: Quality Manual, Procedure Documents, Work Instructions and Records & Forms.
Compliance Control of Design and Development
  • Full-process specification covering design input, design output, design verification and design validation.
Compliance Management of Procurement and Suppliers
  • Supplier assessment, procurement verification, approved supplier list.
Effective Implementation of Corrective and Preventive Actions
  • Establish nonconforming product control and CAPA system to ensure effective implementation of corrective and preventive actions.
Institutionalization of Internal Audit and Management Review
  • Institutionalize internal audit and management review to satisfy annual self-inspection requirements of GMP.
Free Consultation