TSI Consultants is skilled in assisting organizations as they encounter facilities design, construction, or adaptation—or as they encounter facilities-related compliance problems.
Through a powerful blend of compliance, regulatory, scientific, and technical expertise, TSI is highly effective in:
Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
Developing environmental and processing-room requirements
Recommending effective flow of materials, equipment, and personnel
Assessing and enhancing facilities requirements vis-à-vis manufacturing, assembly, packaging/labeling, and distribution operations
Addressing the facilities requirements of laboratory operations
Performing factory acceptance testing of equipment (FAT)
Conducting audits during construction and installation phases
Qualifying facilities for sterile, low-bioburden, and non-sterile products
Qualifying facilities for intermediates, APIs, and finished drug products
Qualifying facilities for medical device components and finished products
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.
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.
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.
