Product Overview
Scale up & Scale down, Technology Development
Changes in manufacturing scale, are very important steps in a product’s lifecycle.
We perform the technical analysis, decide if an experimental design is needed /feasible (QbD), perform the small-scale optimization and technical scaling tests, together wit a regulatory impact analysis.
Based on those experimental data, we model the process, transfer the manufacturing process to the larger/ smaller scale and perform the verification or validation runs. Certainly, project management, all GMP documents, qualifications/ validations are performed as well.
Your advantages:
•Solid and robust transfer models
•Optimized manufacturing process
•Technical and regulatory documents from one team
•End to end process
•Your resources keep focused on their key activities
•Short time to market
•Own tech center for technical trials and tests
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