SERVICES

We provide consulting and project management services to the Medical Device, Pharmaceutical and Bio-pharmaceutical industries

We have a proven track record of helping companies avoid and overcome compliance problems. We have successfully completed compliance programs and the introduction of new products to the global market. A focused core team approach has proven invaluable in creating sustainable quality systems that serve companies’ regulatory and business needs.  We utilise industry leading project management techniques and tools that provide the discipline needed to remain focused on the clients’ objectives.

KEY SERVICES

  • We are experts in compliance management
  • We have supported clients on a local and global basis in resolving FDA form 483 and EIR Issues, Import bans, warning letters, notified body actions and FDA consent decrees
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  • We provide “A” players that will assist you to maximise your business potential
  • We fully source and screen all potential candidates to present the best talent
  • We provide high calibre leaders for interim management roles
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  • We help you maximise your business potential by providing proven leaders as Interim Project Managers to drive short and long-term projects
  • We help you to maximise your abilities, save your time and resources, and provide invaluable business guidance when you need it most
  • We have a very structured PM system which greatly assists you to achieve your goals
  • We help you select the right team and structure to accelerate and deliver your projects on time
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We provide a range of Custom Quality System related services to help maximise your business potential, including

  • Due Diligence audits to support your merger and acquisition strategy
  • Post-merger and acquisition strategy
  • Supporting clients in Quality system remediation resulting from Consent decree, Warning Letters, FDA form 483 & EIR Issues, Notified body and competent authority audits and actions
  • Quality culture transformation
  • Training/Mentoring
  • Lean quality supply design
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  • We have a proven track record in assessing and restructuring organisations to ensure they maximise their business potential
  • We help you to define how tasks are allocated, coordinated, actioned and managed to ensure alignment with organisational goals
  • Trinzo Consulting will help you to LEAN and optimise your structure to enable you to make faster and more informed business decisions
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  • We provide proven talent to fill your interim leadership roles
  • We provide interim leadership to companies seeking to address immediate challenges by adding critical staff for specific projects or to temporarily add knowledge or expertise where needed
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  • GxP compliance strategies
  • GxP audits
  • Internal audits
  • Supplier audits
  • Pre-approval inspection (PAI) readiness
  • Assistance during inspections/post-inspection correspondence and meetings
  • Training in GxP compliance and topical issues
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  • Audits
  • CAPA
  • Complaint Handling
  • Quality Culture
  • Quality Systems
  • LEAN
  • Statistics
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KEY COMPETENCIES 

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COMPLIANCE
MANAGEMENT

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OPERATIONAL
EXCELLENCE

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CULTURE
DEVELOPMENT

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DELIVERING
RESULTS

WHY WORK WITH US?

RESULTS

GET IN TOUCH TO ARRANGE A CONSULTATION TODAY