Excellence in Pharmaceutical CMC Consulting

Case Studies

Selected contributions to the success of our clients

Genotox impurity analysis

Guided method development and established a limit strategy to control the impurity in the drug substance. The impurity does not possess a chromophore, and derivatization followed by HPLC was required. The contract lab screened various methods, but could not advance the method due to high recovery results. Live Oak researched the derivatization chemistry and developed a detailed protocol to direct experiments within budget. The impurity was successfully measured and the project advanced. Limits were established in harmony with industry publications and EMEA guidance.

Clinical strategy based on Biopharmaceutical Classification System

Informed client of the opportunities for streamlining clinical development based on the BCS properties of the development compound. The approach will save time and cost of late-phase bioavailability studies.

Sustained release formulation development

A sustained release formulation project was experiencing stability problems under accelerated stability. As part of a team of consultants assembled by the client, we carried out literature research on sustained release polymers to interpret experimental observations. Live Oak’s suggestions contributed to the consensus and eventual selection of the formulation platform.

Drug Master File (DMF)

Live Oak Pharmaceutical Consulting provides the US Agent service for a European DMF holder. FDA interactions and DMF submissions occur through James Bernstein as the US Agent. Regulatory advice and technical writing for DMF content and process are regularly provided. Assistance was also provided in preparation for a successful Pre-Approval Inspection (PAI) preparation.

NDA and analytical data review

Drug substance and drug product (Module 3.2) sections were reviewed for the client. Consensus content was created from collected reviewer comments. Analytical reports covering method validation, stress testing, and stability testing were reviewed and checked for accuracy against original data and internal consistency. Assistance was given in problem solving troublesome analytical methods, resulting in improved method performance.


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