TUNNELL CREATES SOLUTIONS THAT HELP YOU MEET EACH COMPLIANCE REQUIREMENTTunnell is a trusted and experienced partner who can help you identify problems and implement solutions to meet compliance requirements. Our seasoned experts, many of whom have agency experience, will work with you and your staff on the shop floor and in the board room to help you proactively avoid future compliance problems.
REPOSITIONING COMPLIANCEOur experts will work with you to address compliance issues by repositioning compliance as an integral part of your overall value chain, thus minimizing potential damage to your firm from regulatory observations and actions.
- cGMP/ cGLP, cGCP Assessments including general cGMP inspection readiness, PAI readiness, facility and equipment design, PART 11 compliance as well as data integrity assessments and due diligence assessments.
- Remediation Support, including review of responses and support for remediation in response to FD483 observations, warning letters or consent decrees including independent third party review of deviation investigations, change controls, validation reports, laboratory investigations, method validation reports, etc.
- Quality Systems Assessments including quality, production, laboratory controls, facilities and equipment, materials and packaging and labeling systems.
DELIVERING SUSTAINABLE RESULTS
The Tunnell team will work side-by-side with your team to assess your processes and systems, identify gaps and raise your level of compliance through the life cycle and across your entire business. We mentor and coach along the way and provide knowledge transfer so that your team can sustain the new way of working.
Walter Matzmorr discusses the cross functional process of planning for a Pre-Approval Inspection.