Scientific and Technical Assistance

TSI CONSULTANTS SERVICES

Scientific and Technical Assistance

One of TSI Consultants’ key differentiators is the cadre of scientific and technical experts. With decades of experience in the industry, the consultants have the real-world knowledge and experience required to deliver accurate, actionable recommendations. Members of the Science and Technology Practice work seamlessly with our other practice groups to deliver results for clients facing difficult compliance and regulatory problems.

Scientific Assistance

TSI Consultants scientific assistance allows clients to:

  • Develop and enhance laboratory controls
  • Perform laboratory investigations
  • Assess bioequivalence studies and evaluate adequacy of bioanalytical methods and laboratories
  • Optimize product formulation and processes
  • Assess product stability

TSI Consultants technical capabilities help clients:

  • Evaluate process designs
  • Develop or refine process control strategies
  • Assess and improve process analytical technology (PAT)
  • Evaluate the development of analytical methods
  • Set specifications

TSI consultants are experts in:

  • Evaluating and enhancing systems to assure data integrity—covering collection, documentation, management, source data changes, and security
  • Assessing data integrity, whether voluntary or required by the DRAP

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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