Technical Transfer
Over 20 years, Bushu Pharma has developed a wealth of experience in technical & QC testing method transfer under USP, EP, JP and ICH protocols.
While technology transfers can oftentimes be characterized by a loss of quality or
continuity from the product’s original purity, Bushu Pharma places the highest priority
establishing a full understanding of the transfer at hand from our customers, taking into
account the need to create speed and efficiency in the formulation process - but
without the loss of quality.
For our existing customers as well as for companies considering a new manufacturer,
you can count on us to handle your technical transfers and inspections from concept to
commercialization with the utmost care.
Our technology transfer experts work with you for:
- Site Transfer
- Equipment Selection and Validation IQ, OQ and PQ
- Existing Process Optimizations
- Batch Record Development
- Validation Protocol Preparation and Execution
- SOP Development and writing
- Alternate Raw Material Evaluations and Reformulations
- In-Plant Troubleshooting and Investigations
- Scale Up Assistance from feasibility to commercialization
Key features of our Inspection and Technical Transfer service
- Fully supportable from early to late stage by SME team
- Manage for each project and/or client by dedicated team consisting of SMEs
- Assign SME, e.g. bioassay, biological, etc. for QC method transfer
- Available bilingual approach, English and Japanese
- Technical Services, PMO and Technical Operation Strategy are under COO in order to manage directly
Quality Management System
Interested in Partnering with us?
