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Small Molecules API Drug Development Services Tech Transfer, Process Safety & Validation Services

Tech Transfer, Process Safety & Validation Services

The critical role of technology transfer

We take a phase-appropriate approach to method transfer and validation. Whether we’re supporting an early-stage program with minimal existing data or a late-stage asset on the cusp of a U.S. FDA or EMA submission, we understand your needs and customize our systems accordingly.

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Tech transfer services

Seamless Transfers

We bring the right team to the table, adapting to your program’s development phase and/or manufacturing scale. Along with the transfer of knowledge and standard operating procedures (SOPs), SK pharmteco can work with your team to further optimize your processes.

Smart Process Validation

We’re highly competent at registering and validating processes, including design of experiments (DoE), critical parameters, limits of detection/quantitation, and more. Once achieved, our team implements continued process verification (CPV), per U.S. FDA guidance, to continually optimize and validate your processes.

Dependable Document Registration

Whether you’re compiling chemistry, manufacturing, and controls (CMC) documentation or preparing for a final NDA, SK pharmteco is a valuable resource. We can draft the necessary validation protocols and reports to support your regulatory and filing needs.

Your Partner for Tech Transfer Services

SK pharmteco assigns a professional, dedicated project manager who takes ownership of your project and works closely with you to define and manage the project scope and deliverables. Our project managers simplify complexity, providing you with a single point of contact globally to ensure your timelines and deliverables are met. Because the efficient exchange of information is especially critical during the project, we communicate with you via routine progress reports and teleconferences at a frequency that meets your needs. This project management approach ensures seamless project execution, fulfilling the highest quality standards on time and in full.

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API Drug Substance Development

Your Partner for Tech Transfer Services

SK pharmteco assigns a professional, dedicated project manager who takes ownership of your project and works closely with you to define and manage the project scope and deliverables. Our project managers simplify complexity, providing you with a single point of contact globally to ensure your timelines and deliverables are met. Because the efficient exchange of information is especially critical during the project, we communicate with you via routine progress reports and teleconferences at a frequency that meets your needs. This project management approach ensures seamless project execution, fulfilling the highest quality standards on time and in full.

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Tech Transfer, Process Safety & Validation FAQs

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