The TSI team includes a powerful blend of consultants with FDA and industry experience—including leading scientific and technical experts who help ensure that recommendations are not only scientifically and technically accurate, but also actionable.

TSI Consultants are particularly skilled in assessing and enhancing quality assurance and controls—from the way technical issues are handled to the organizational structure of quality units.

Leveraging vast knowledge and experience, TSI Consultants assists clients in:

• Evaluating written procedures and standard operating procedures
• Helping to interpret regulations in concert with industry standards
• Developing laboratory quality, analytical methods, methods validations, and product component specifications
• Creating a program to meet current FDA expectations for GCP Compliance
• Consulting self-evaluations
• Building sampling plans
• Performing trend analysis
• Providing corporate oversight programs and enhancement—including good governance practices; corporate quality/compliance functions and oversight practices; and independent advice to CEOs, senior managers, and board members
• Implementing site oversight programs, including internal audits and performance metrics
• Reviewing and enhancing management controls
• Reviewing and enhancing organizational structures—including functions, reporting relationships, responsibilities, staffing and competence; communication systems and performance (vertical and horizontal); and independence, staffing, and competence of quality units