While life sciences companies are required to report a “significant loss” of prescription drug samples to the FDA, there are no clear guidelines for defining “significant.” To enable life sciences organizations to satisfy reporting requirements, Porzio Pharmaceutical Services created Significant Loss Threshold Assurance, a customized, formula-based approach to sample accountability.
Using Significant Loss Threshold Assurance, PPS provides companies with tailored thresholds for each sampled product. Incorporating 16 key variables, our propriety formula sets significant thresholds that account for an organization’s individual distribution model, historical sample loss records, and full product portfolio. As a company’s distribution model or product portfolio changes, PPS reassesses sample data to ensure continuous compliance.
To learn more about Significant Loss Threshold Assurance contact here or contact a PPS representative.