• 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

• 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

• 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
• Training/Mentoring
• 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.

• 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

• Audits
• CAPA
• Complaint Handling
• Quality Culture
• Quality Systems
• Complaint Handling
• LEAN
• Statistics

• Safety Planning
• Safety Review
• Training assessments
• Safety Consultancy