Since 2010, PTSI has provided strategic technical oversight and client representative support to the biotechnology and advanced therapeutics industries, including cell and gene therapy, viral vectors, CAR-T, T-cell therapies, mRNA, vaccines, radiopharmaceuticals, and medical devices.

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We deliver senior-level Client Representation and integrated technical expertise from our multidisciplinary Subject Matter Experts across Quality Assurance, Regulatory Compliance, Quality Control, Engineering, Manufacturing, Facilities Design and Construction, Reliability-Centered Maintenance, Process Development, Technology Transfer, and end-to-end project execution. Our expertise spans from development through GMP manufacturing and commercialization, supporting complex and highly regulated therapeutic platforms.

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PTSI professionals average more than 20 years of experience serving in client-side leadership roles. Having operated as “the client,” we leverage this perspective to anticipate program risks, align with regulatory expectations, and implement practical, innovative solutions grounded in current industry guidance and global regulatory standards.

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Our commitment to technical excellence, disciplined execution, and measurable results has earned sustained client confidence across the United States and internationally. With a proven history of industry leadership, we have supported the successful delivery of compliant, high-performance biopharmaceutical programs in some of the industry’s most advanced and demanding environments.