Tunnell Consulting - Consultants to Management

Pharmaceutical Technical Services
Tunnell Consulting has a highly-credentialed staff of scientists, engineers and technical experts who help the pharmaceutical industry meet tough regulatory, legislative, stockholder and competitive demands. We deliver results in technical services, manufacturing, quality assurance/control, engineering and distribution. In addition, our Performance Excellence and Supply Chain/Transportation practices also serve the pharmaceutical industry, and bolster our technical services with process excellence and supply chain optimization.

Product Development

Formulation Development
Manufacturing Process Validations
Excipient/Ingredient Selection
Analytical Methods Development
Technology Transfer (More Details)
Manufacturing Scale-Up Support
Development Report Writing

Technical Services

Total Technology Management (Article)
Technology Transfer (More Details)
Equipment Validation (IQ, OQ, PQ)
Manufacturing Process Troubleshooting

Manufacturing/Production Support

Cleaning Methods Development and Support
Vendor Certification Process Design and Implementation
Process Cycle Time Reduction
Critical Path Management
Barrier/Isolation Systems Design
Sterilization Cycle Development
Water Systems Validation
Aseptic Manufacturing Systems Design
Filling and Packaging Process Design and Validation
Documentation Systems Assessment and Redesign

QA and Regulatory/Compliance

cGMP/Quality Systems Auditing
Quality Systems Management and Remediation
Stability Program Design and Implementation
Regulatory Submissions Preparation -- CMC Sections
Operations Policies and SOPs
Training and Training Documentation Audits
Process Drift Audits
Vendor Audits

Computer Validation

21 CFR Part 11 Compliance
Computer Systems Compliance Auditing
Validation Master Planning
Validation Training
Y2K Compliance
LIMS Configuration and Validation

Laboratory and Analytical Services

Method Development
Method Validation
Cleaning Validation
Analytical Testing
Equipment IQ, OQ, PQ
Laboratory Capacity and Systems Design Assessment
Laboratory Process Design and Improvement
Development of a Compliance Infrastructure and Culture Including:
- Laboratory Compliance Systems Design and Implementation
- SOP Guidance Document Preparation
- Laboratory Performance Auditing Process Design and Implementation
- cGMP and Laboratory Systems Training Program Development
- Laboratory Management Control Systems Development and Implementation
- Laboratory Training Program Design and Implementation
- Personnel Qualification/Disqualification and Requalification Procedures Development
- Job Description Revision/Development
- Personnel Qualification Monitoring and Record Maintenance Process Design and Implementation

Educational / Training Services

Click here for information on our Educational and Training Services for clients.