SCHEDULE 8 REGULATORY ASSURANCE

Independent Assurance Throughout the
Project Lifecycle


Risk Group works alongside clients, architects, engineers and
project teams from project definition through to licensing and
ongoing operation, helping identify and resolve security and
regulatory issues before they become costly problems.

Why engage early?

Early involvement allows security and regulatory requirements to be integrated into the project from the outset, reducing risk, cost and delay.

We help you understand compliance obligations, assess risks, establish clear security objectives and set the foundation for efficient design and construction.

Our independent assurance continues through construction, commissioning and operation.

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The greatest opportunity to reduce project cost, redesign and licensing risk occurs before construction begins. ''

Independent Assurance Throughout the Project Lifecycle

Our assurance spans the entire project lifecycle, providing continuity, oversight and confidence at every stage.

  1. Define
  2. Design
  3. Build
  4. Commission
  5. Operate
  6. Review
Define

Establishing the right strategy

  • Licensing strategy
  • Risk assessment
  • Site and operational review
  • Security objectives
Design

Integrating compliance into the solution.

  • Architectural review
  • Security design
  • Access control
  • Physical security
Build

Maintaining assurance during construction

  • Site inspections
  • Compliance reviews
  • Design change assessment
  • Builder liaison
Commission

Preparing for licensing.

  • Operational procedures
  • Security management
  • Pre-inspection audit
  • Department liaison
Operate

Supporting ongoing compliance.

  • Operational reviews
  • Governance support
  • Facility modifications
  • Compliance monitoring
Review

Continuous improvement.

  • Independent reviews
  • Lessons learned
  • Risk reassessment
  • Future capital works

Experience You Can Rely On

For more than two decades, Risk Group has provided independent security, regulatory and governance assurance services to organisations handling Schedule 8 medicines throughout Australia.

Our experience spans pharmaceutical manufacturing facilities, national distribution centres, hospitals, research organisations and community pharmacies, supporting clients through planning, design, construction, commissioning and ongoing operation.

We deliver practical, independent advice that integrates security, governance and regulatory compliance to help you achieve safe, compliant and resilient outcomes.

Typical Projects

  • Pharmaceutical manufacturers
  • Pharmaceutical wholesalers
  • Hospital pharmacies
  • Community pharmacies
  • Research organisations
  • Healthcare providers
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Planning a Schedule 8 Facility?

Whether you're planning a new facility, expanding an existing operation
or preparing for Department of Health licensing, Risk Group can help.

Stephen Frost

Founder and Principal Consultant


Phone number
+61 412 331 564
Address

PO Box 158, Lennox Head, New South Wales, Australia 2478