We can provide a comprehensive strategy of identification, quantification, and approaches for minimization of unwanted chemical entities that may arise from starting materials, reagents, solvents, catalysts, processing conditions, or degradation pathways. In addition to the development of robust processes, we can help companies determine impurity kinetics of formation, fate and purge, establish process stable hold points, and/or storage conditions. We also use accepted techniques, such as Monte Carlo simulations, to help you define justifiable acceptance criteria based on process and analytical variability.

Nitrosamines. Our team has pioneered several of the experimental and theoretical approaches currently used for drug substance and drug product nitrosamine risk assessments. We have a proven track record and hands-on experience developing risk assessments for drug substance and drug product processing and storage, in preparation for regulatory filings, and answering regulatory questions.

Spec Justification. A well thought out specification justification is critical in getting your product approved without push backs. We have extensive experience in identifying the right data and developing the associated scientifically sound rationale supporting the chosen acceptance criteria. We design targeted experiments and deploy models to justify the control strategy, specifications, in-process controls, determine normal operating ranges, desired manufacturing ranges, proven acceptable ranges, design space limits, etc. We provide a comprehensive perspective that explains how the specification limits, based on development data, fate and purge studies, and batch history is directly linked to the control strategy, including the manufacturing process and analytical methods.