Tunnell Consulting
Tunnell Consulting is a life sciences consulting firm dedicated to delivering sustainable results through solving complex problems, managing costs, gaining regulatory approval, and impacting humankind. They support clients across various stages of product development, manufacturing, and supply chain management, with a focus on quality, regulatory compliance, operational excellence, and strategic development in the pharmaceutical, biotechnology, vaccines/biologics, and government sectors.
Industries
Nr. of Employees
medium (51-250)
Tunnell Consulting
Patents
Regimens of tafenoquine for prevention of malaria in malaria-naive subjects
US-12616689-B2
View DetailsRegimens of tafenoquine for prevention of malaria in malaria-naïve subjects
US-11744828-B2
View DetailsRegimens of tafenoquine for prevention of malaria in malaria-naive subjects
US-10888558-B2
View DetailsRegimens of tafenoquine for prevention of malaria in malaria-naive subjects
US-10342791-B2
View Details
Regimens of tafenoquine for prevention of malaria in malaria-naive subjects
US-12616689-B2
View DetailsRegimens of tafenoquine for prevention of malaria in malaria-naïve subjects
US-11744828-B2
View DetailsRegimens of tafenoquine for prevention of malaria in malaria-naive subjects
US-10888558-B2
View DetailsRegimens of tafenoquine for prevention of malaria in malaria-naive subjects
US-10342791-B2
View DetailsServices
Consulting to improve and maintain a robust quality function, including system design, remediation and quality culture transformation.
Regulatory planning and support across the product lifecycle, including inspection and PAI readiness.
Development and implementation of compliance programs and remediation plans to meet regulatory and internal requirements.
Advisory support for early‑stage development and clinical planning to align regulatory and development activities.
Application of lean and operational excellence methodologies to improve efficiency, throughput and process reliability.
Technical problem solving for manufacturing including process understanding, optimization and scale considerations for biologics and vaccines.
Consulting to improve and maintain a robust quality function, including system design, remediation and quality culture transformation.
Regulatory planning and support across the product lifecycle, including inspection and PAI readiness.
Development and implementation of compliance programs and remediation plans to meet regulatory and internal requirements.
Advisory support for early‑stage development and clinical planning to align regulatory and development activities.
Application of lean and operational excellence methodologies to improve efficiency, throughput and process reliability.
Technical problem solving for manufacturing including process understanding, optimization and scale considerations for biologics and vaccines.
Expertise Areas
- Quality management systems
- Regulatory compliance and inspection readiness
- Supply chain and strategic procurement
- CDMO/vendor management and oversight
Key Technologies
- Lean manufacturing and lab improvement methods
- Statistical process control and descriptive statistics
- Electronic document management systems (EDMS)
- Continued Process Verification (CPV)
News & Updates
December 5, 2024 newsletter highlighting updates and insights.
Webinar discussing quality management in contract manufacturing organizations.
Case study on making ‘right-first-time’ a way of life in a critical production facility.
Recognition for contributions to BARDA projects.
Discussion on quality management strategies in biopharma.
Discussion on the importance of de-risking sourcing.
December 5, 2024 newsletter highlighting updates and insights.
Webinar discussing quality management in contract manufacturing organizations.
Case study on making ‘right-first-time’ a way of life in a critical production facility.
Recognition for contributions to BARDA projects.
Discussion on quality management strategies in biopharma.
Discussion on the importance of de-risking sourcing.