Systems Evaluation

TSI CONSULTANTS SERVICES

Systems Evaluation

Clients frequently turn—and return—to TSI Consultants for world-class evaluations of their R&D systems, manufacturing systems and processes, and quality control/assurance systems. Just as important, they trust TSI to make powerful, effective recommendations for enhancing current systems and processes.

TSI recognized experts in R&D and manufacturing systems assessments routinely assist clients in:
  • Implementing quality by design for successful commercialization
  • Analyzing and managing risk in the R&D and manufacturing environments
  • Developing requirements and performing audits for clinical material GMP (Phases I, II, and III)
  • Assessing and streamlining development practices
In the realm of quality control and quality assurance systems, TSI consultants are the “go-to” people when needs include:
  • Assessing and managing risk vis-à-vis quality systems
  • Evaluating and enhancing quality unit roles and responsibilities
  • Assessing and improving facilities and equipment systems, materials systems, production systems, and laboratory controls systems

PHARMACEUTICAL

TSI Consultants has an unsurpassed reputation for excellence in technical, regulatory consulting

PHARMACEUTICAL

TSI Consultants is proficient in the development, implementation, and management of diversified projects involving compliance, scientific principles, technical aspects, and regulatory requirements related to pharmaceutical products.
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Medical Device

TSI Consultants comprehensive list of services extends to all classes of medical device.

Medical Device

TSI Consultants comprehensive list of services extend to all classes of medical devices and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.
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BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation,

BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation, and guidance services for biologics, including cell and gene therapy, human cell and tissue products, monoclonal antibodies, biosimilars and many more.
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