SERVICES
Tech Transfer and
Process Development
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In-depth Client Assessment
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CDMO Assessment and Pre-Approval
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Process Definition
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Project Management Support
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SME Support for Tech Transfer
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Process Training
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Regulatory Assessment
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PTSI Document Library: SOPs, Checklists, Etc
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Person in Plant support for Manufacturing/ Quality
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PTSI evaluates all aspects of our clients' processes, needs, restrictions and limitations, and overall strategy.
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We also audit our partner CDMOs in order to develop a comprehensive, best-suited recommendation for our clients.
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Our experienced professionals in the CG&T Tech Transfer and CDMO spaces thoroughly vet potential partner CDMOs in all aspects, including: phase and scalability, capacity limitations, assay development, quality strategy and policy, QC support and assay development, supply chain, raw material sourcing, vendor qualification, and general best practices.
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Based on our experience in this space, we can adequately balance our clients' requirements and 'nice to haves' with budget and time limitations while keeping in line with the overall strategy and forward-looking goals when recommending a CDMO partner.
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PTSI fully partners with our client and can serve as the person-in-plant (PIP) to oversee all aspects of the CDMO tech transfer process and ongoing manufacturing.