Internal & External Audit Services

Internal auditing is an objective assurance and consulting activity designed to add value and improve an organization's operations. It can help an organisation accomplish its strategic objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance processes. Evaluation on the current state of control, risks and governance are undertaken in order to determine how to improve business operations. Experienced Infostrat Consulting internal audit team will provide valuable information to company boards, audit committees and company executives to better manage risk and improve operational efficiency.

Governance Review

An Internal Audit Engagement would result in the following:

  • Develop, fulfill and maintain a company's ongoing internal audit function
  • Perform quality reviews on a company's internal audit function
  • Augment a company's existing internal audit staff
  • Provide assistance with the development of a company's internal audit function
  • Offer advisory services to audit committees and senior management

Inspection Readiness

  • European Medicines Agency (EMA)
  • Food and Drug Administration (FDA - USA)
  • Medicines and Healthcare Products Regulatory Agency (MHRA - UK)
  • Therapeutic Goods Administration (TGA - Australia)
  • Medicines Control Councel (MCC - South Africa)
  • Swiss Agency for Therapeutic Products (Swissmedic)
  • Pharmaceuticals and Medical Devices Agency (Pmda - Japan)

Key Services

  • Internal Controls Review
  • Risk & Compliance Management Review
  • ISO 27001 Pre-Certification Assessment or Gap Analysis
  • ISO Implementation (9001 and 13485)
  • GxP Implementation in Pharmaceutical, Medical Devices and Fast-Moving Consumer Goods (FMCG) industries.
  • Vendor or Third Party Supplier Assessment
  • GDPR Implementation

Types Of Audits

  • Sarbanes-Oxley (SOX) Compliance
  • General Data Protection Regulation (GDPR)
  • ISO 27001 - Information Security
  • ISO 9001 - Quality Management System
  • ISO 13485 - Medical devices
  • Good Distribution Practice (GDP)
  • Good Manufacturing Practices (GMP)
  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practice (GPvP)
  • Good Clinical Data Management Practice (GCDMP)