THE CQV TEAM OF PROJECT PROFESSIONALS
We are ‘the’ most highly skilled team of experienced, Pharmaceutical, Medical Device, Biotechnology and Compliance specialists available who are focused on providing solutions that are value adding, cost effective and results driven.
WHO WE ARE
A team of industry experts committed to providing the highest standard of services and innovative solutions for your business
A SIMPLE GOAL
We help your business Quality and Processes be more effective and compliant, enabling you to maximise your business potential
HOW WE DO THIS
Embedding ourselves into and being an extension of your company, not only consulting but facilitating the achievement of your goals
Highly experienced Staff, Processes, Quality and Results
- 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, and remediation projects
- 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 caliber leaders for interim management roles.
- 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.
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
- Lean quality supply 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
- 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
- Complaint Handling
- Quality Culture
- Quality Systems
- Complaint Handling