Tunnell Consulting

Tunnell Consulting helps life sciences companies solve the process problems that put product quality at risk and gain regulatory approval, from a streamlined operation to the paperwork that gets them through the FDA. Its work includes compliance assessments, QMS and remediation support, regulatory submissions and agency interactions, and development-stage planning.

Quality, Compliance and Remediation

• Address GxP compliance through cGMP, cGLP, and cGCP assessments, including inspection readiness, Part 11 compliance, data integrity assessments, and due diligence assessments.
• Build and improve quality management systems through QMS design, global QMS management, SOP authoring support, root cause analysis, CAPA management, quality risk management, and maturity assessment. Tunnell also supports remediation related to FDA 483 observations, warning letters, and consent decrees, including review of responses and selected investigations, change controls, validation reports, and laboratory investigations.

Regulatory Strategy and Submissions

• Develop regulatory strategy covering CMC strategy, filing strategy, comparability protocols, specification development, and preparation for and participation in agency meetings.
• Support regulatory filings through CMC authoring and publishing, submission preparation, and post-marketing CMC management, including supplements, changes being effected, and annual reports. Tunnell also supports IND strategy and regulatory applications from early development through first-in-human studies.

Manufacturing Science and Technology Transfer

• Plan and implement technology transfer, including process characterization and process performance qualification support; related manufacturing science work includes formulation development, analytical method development, and equipment qualification.
• Support facilities and laboratory operations through lab operations support and facilities start-up, while applying process improvement and quality expertise to manufacturing and development activities.

Clinical, Operating Model and Sourcing Support

• Advise on early-stage clinical planning, including protocol and trial design, clinical pharmacology and data management; Tunnell also helps select and manage CROs and CDMOs.
• Design operating models and organizations, support transformation and change management, and apply strategic sourcing to drug development, clinical trial, and market authorization activities.

Best Fit

• Life sciences companies needing consulting support for GxP compliance, QMS improvement, remediation, regulatory strategy, or CMC submissions.
• Organizations planning technology transfer, manufacturing process characterization, early-stage clinical activities, CRO or CDMO selection, or operating-model and sourcing changes.