Technology Transfer
Our Technology Transfer System provides our clients a smooth product and/or technology transfer. It integrates all critical steps ensuring that the transfer process is consistent in meeting with cGMPs regulations while complying with all other governing codes, laws and regulations. We execute a well-designed product or technology transfer focusing in the following areas:
- Project timeline implementation
- Facility / Utilities / Equipment requirements
- Manage Budget
- Evaluate in-house resources and specific training needs
- Documentation Audit (Specifications, SOPs, Batch Records, Protocols, Reports, etc.)
- Execution of feasibility or demonstration batches
- Scale-up
- Manufacturing & Site Changes
- Process Optimization
- FDA Submission Packages
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