Regulatory, Compliance & Quality
Tunnell is a trusted and experienced partner who can help you address compliance requirements while improving business processes, reducing both cost and risk. Our experts, many of them veterans of the FDA, can help you proactively avoid future issues and reposition compliance as an integral part of your overall value chain. No other consulting firm offers such a breadth of services in support of your regulatory, compliance and quality needs.
Regulatory Risk Management
Our proprietary enterprise risk assessment process provides a detailed risk- and ROI-based analysis to help you make informed, risk-based decisions regarding mission critical compliance-related issues. This process provides management level strategies, as well as a blueprint for execution of enterprise-wide solutions to address current and potential issues and to optimize your quality and regulatory operations.
Compliance Enabling Technology
Tunnell provides services and strategies for the use of technologies to help assure compliance and quality. These services include submissions and management technologies, knowledge and content management, and regulatory processes such as computer system validation.
Regulatory, Compliance, and Quality Areas of Expertise Include:
- FDA and Other Regulatory Authority Strategy and Consulting
- R&D Consulting Including Product Safety and REMS
- Corporate Governance
- Commercial Regulatory Services
- Quality Systems
- cGMP Compliance
- Pre-approval Inspections
- Pharmacovigilance
- Compliance Remediation
- Quality by Design (QbD) and ICH
For more information regarding our services, please visit our Library.
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