Strategic Consulting

Strategic Consulting

Our team provides full service consultancy support for the Medical Device, Pharmaceutical and Bio-Pharmaceutical Industries 

Our highly-qualified and highly-focused medical device consultants are experts in quality and regulatory compliance requirements. By utilising our deep industry experience, we identify obstacles and develop enduring strategies to solve the unique challenges that your products and teams are challenged with.

Our global network of consultants can support you through all aspects of the medical device regulatory approval cycle both on-site and remotely, anywhere in the world. 

We can support you with:

  • Organisational Design
  • Quality Management Systems (QMS)
  • Quality and Regulatory Process
  • Clinical Strategy
  • Manufacturing
  • Culture and Behaviour
  • Remediating Audit Findings
  • Technical Documentation
  • Product Registration
  • Verification and Validation
  • Standards Compliance
  • Recalls and Adverse Event Management
  • Product Design

The Trinzo Apex Approach

We have developed a simple, easy to follow, three phased approach to break down projects into concise phases: APEx.  

  • Phase 1: Assess
    During this phase we will assess all relevant information required to establish the current status, desired status, constraints and any other relevant information.
  • Phase 2: Plan
    In this phase, we develop a structured plan and execution strategy. This outlines how we will be successful in achieving the objectives.
  • Phase 3: EXecute
    During this phase we execute the plan in line with the agreed charters. We will report on the progress being made at predefined intervals.

Ready to discuss your project? Contact us today to book in your free, no obligation consultation.

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