Expert guidance for your analytical strategy
Identify attributes • Identification of attributes
Validate methods • In line with ICH Q2(R2) validation of methods applied to critical Quality Attributes (batch release, stability studies) Trending • Monitoring of method performance • Monitoring of product attributes along its lifecycle
• Product knowledge • Forced degradation Develop method • Adequate selection of technology and instrument • Proof of concept study to confirm methodology Fit-for-purpose • Assessment of analytical procedure performance • Documentation of analytical procedure (including control strategy)
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