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Chemistry, Manufacturing, and Controls (CMC)
Quality by Design (QbD) principles are applied to meet consistent product quality at different stages of development
A well-characterized drug product is the foundation for a well-defined control strategy for consistent drug manufacturing and testing.
Regulatory strategy
The goal is to define the adequate regulatory strategy to ease approval of your regulatory submissions to minimize delays in commercialization or avoid drug shortages.
De-risking approaches include: (1) in depth gap analysis of comparability protocols, (2) evaluation of quality control (QC) method performance during tech transfer, and (3) assessment of potential clinical consequences of CQA changes on safety and efficacy profiles.
Integration of data
How? By integrating your product and process knowledge to predict potential clinical risks associated to changes in attributes directly associated to its safety, exposure, and activity.
Translational approach
Manufacturing process parameters that can impact CQAs are carefully analyzed side-by-side ”in vitro” evaluation of biological activity and drug disposition aspects to define the need for supportive preclinical and clinical evidence.
Risk prioritization
Changes in post-translational modifications, product variants, and process-related impurities are carefully analyzed to reduce the need of additional clinical evidence.
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