Technical Transfer Documents

We understand the need to move rapidly through clinical development, QSI associates can efficiently scale up the drug product manufacturing processes from Phase I to meet the demands of later clinical trial requirements and ensure a seamless transition to larger-scale manufacturing and drug product commercialization. QSI Associates will prepare the technical transfer documents needed by the CMO or CRO. Development reports, proposed specifications (raw materials, finished product and componentry), Process flow diagrams, proposed batch records, labeling and packaging etc.can be prepared or reviewed by QSI. .

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Managing the CDMO or CRO

QSI associates can provide Project Management and Technical SME services for your organization with the CMO or CRO. QSI can create a project timeline, chair standing meetings and issue meeting minutes to the integrated team. QSI can review and provide guidance on Analytical and microbiological method development, proposed method of manufacture, raw material and componentry specifications, packaging and labeling, stability protocols, container closure studies, E&L studies and batch records from the CMO. QSI can also author all of these documents for your organization as a service provider. QSI can be on site, during engineering and registration batches. complete data analysis and author reports.

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Human Factor Studies - Medical Device or Combination Products

QSI can review human factor studies protocols, from a 3rd party and be on site while they are executed looking after your organization's interests.