TUNNELL CREATES SOLUTIONS THAT HELP YOU MEET EACH COMPLIANCE REQUIREMENT

Tunnell 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 COMPLIANCE

Our 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, PAI

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

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 MANAGEMENT SYSTEMS

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.

Published

James Darnell

James P Catania – BioPharm International- July, 2010

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