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 utilize industry leading project management techniques and tools that provide the discipline needed to remain focused on the clients’ objectives.

KEY SERVICES

COMPLIANCE MANAGEMENT
  • We are experts in compliance management
  • We have supported clients on a local and global basis in resolving 483’s, import bans, warning letters, notified body actions, FDA consent decrees
  • Remediation projects
  • Safety Oversight and Consultancy
TALENT ACQUISITION & REMOTE SUPPORT
  • We provide “A” players that will assist you to maximize 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.
  • Project Management oversight
  • CQV readiness review
  • Document Preparation
PROJECT MANAGEMENT
  • We help you maximize your business potential by providing proven leaders as Interim Project Managers to drive short and long-term projects.
  • We help you to maximize 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 in achieving your goals.
  • We help you select the right team and structure to accelerate and deliver your projects on time.
QUALITY SYSTEMS

We provide a range of Custom Quality System related services to help maximise your business potential.

  • Due Diligence audits to support your merger and acquisition strategy
  • Post merger and acquisition strategy
  • Support clients in Quality system remediation resulting from Consent decree, Warning Letters, 483, Notified body and competent authority audits and actions
  • Quality culture transformation
  • Training/Mentoring
  • Lean quality supply design
ORGANISATIONAL DESIGN
  • We have a proven track record in assessing and restructuring organisations to ensure they maximize their business potential
  • We help you define and element how activities, task allocation, coordination and management are directed towards organisational goals
  • We will help you to LEARN and optimize your structure to enable you to make faster and better business decisions
INTERIM LEADERSHIP
  • 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.
AUDIT & INSPECTION
  • 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
TRAINING NEEDS
  • Audits
  • CAPA
  • Complaint Handling
  • Quality Culture
  • Quality Systems
  • Complaint Handling
  • LEAN
  • Statistics
SAFETY MANAGEMENT & CONSULTANCY
  • Safety Planning
  • Safety Review
  • Training assessments
  • Safety Consultancy

WHY WORK WITH US?

RESULTS

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Contact

CQV TEAM

Focused on providing consulting services and solutions for the medical device, pharmaceutical and bio-pharmaceutical industries across all sectors, Engineering, Commissioning, Validation, Quality , Remediation and Compliance.

CONTACT US

Innovation Centre

Dublin
Ireland

EMAIL
[email protected]
© Copyright - CQVTeam 2019
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