A large, international pharmaceutical manufacturer with multiple products in development needed their active pharmaceutical ingredients classified into a control banding scheme. Affygility Solutions responded to the client’s needs and prepare comprehensive potent compound classification monographs within the client’s timeframe and budget.
A large, international pharmaceutical manufacturer with multiple products in development and currently marketed products.
Internal policies required that all active pharmaceutical ingredients be classified into a control banding scheme prior to entry into the facility. Timeline from the time of the request of the potent compound classification report to the needed delivery date was generally less than two weeks.
Upon request of the report, Affygility Solutions expeditiously deploys resources to begin the scientific and toxicological data research. Our Ph.D. degreed toxicologist reviews all available data, calculates a numerical occupational exposure limit, classifies the compound into the company’s banding scheme, and prepares a detailed written report.
Client enjoys the benefit of having a trusted resource to perform these reviews in a timely manner, therefore, allowing them to rapidly bring in new compounds for development.