Late Development/Marketed Products
Characterization of a natural product for new regulatory filing
Goal: Collect additional data on a natural product for differentiation of materials and correlation to performance.
Action: Worked with contract laboratory to develop a step wise approach for the physical characterization of the matrix of the natural product and its effect on performance, along with the level of the active ingredient.
Result: New characterization methods for the matrix employed to show sameness of the natural product.
Review of data for investment opportunity
Goal: Determine if natural product/device combination is feasible for development.
Action: Reviewed scientific documents and compiled a list of considerations for a regulatory filing.
Result: Additional work suggested to ensure success of the investment.
Development of a quantitative solid form method for release of API in a marketed drug product
Goal: Develop a robust quantitative method for the desired form in the presence of two other crystalline phases.
Action: Worked with the client and CRO to develop and validate a quantitative method to submit to regulatory agencies.
Result: A robust quantitative solid form method was developed for API release and sucessfully submitted to regulatory agencies.
Review of physical stability data for NDA filing
Goal: Determine if crystal form changes had occurred during stability studies.
Action: Reviewed long term API stability data and compiled a statement for the regulatory filing.
Result: Documentation for NDA filing provided on the results of the physical stability study.
Compilation of solid-state data for patent application
Goal: Determine and compile the requisite solid-state form data to be included in patent.
Action: Reviewed screening, characterization, and crystallization reports to find suitable data for filing; interfaced with characterization laboratory and patent atttorneys to compile relevant data for patent application.
Result: Patent application on multiple solid forms was written and submitted.