Consulting services and solutions for the Medical Device, Pharmaceutical and Bio-Pharmaceutical industries
- We are experts in compliance management
- We have supported clients on a local and global basis in resolving 483, import bans, warning letters, notified body actions and FDA consent decrees
- 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.
- 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 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 maximise 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 LEAN and optimise 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.
- 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
We are focused on providing consulting services and solutions for the Medical Device, Pharmaceutical and Bio-pharmaceutical industries
A team of industry experts committed to providing the highest standard of services and innovative solutions to you
A SIMPLE GOAL
We help you to be more effective and compliant by enabling you to maximise your business potential
WE DO THIS BY
Embedding ourselves into and being an extension of your company, facilitating the achievement of your goals
OUR SKILLED AND INNOVATIVE TEAM
- We are enthusiastic
- We are experienced
- We are highly-driven
- We are a power network
- We are Leaders in change solutions
- We specialise in Quality and Regulatory problems
- We have an abundance of experience in solving complex issues
- We meet the demands of the ever-changing global environment