The generic consistency evaluation is composed by quality conformance and efficiency consistency. Evaluation of pharmaceutical quality conformance is defined to determine whether your generic drug preparation and reference formulations are consistent with the key quality indexes such as the dissolution and related substances. Treatment efficacy consistency is evaluated by bioequivalence assay.
As regulated by the FDA, the quality of the generic drugs should meet the standards for brand name drugs. To ensure your generic products can meet the strictest demand for scrutiny, the ingredients including active agents and the inactive components, clean class and facilities at BOC Sciences are all required to meet the federal guidelines for Good Manufacturing Practices.
The major advantage for generic medicines compared with the innovator counterparts is the cost benefit, because they do not have to demonstrate the safety and effectiveness through the costly animal and clinical (human) studies that are required for the innovative drug companies.
In the field of generic quality consistency evaluation, we have successfully completed multiple quality consistency evaluation cases and generic drugs researches. With access to advanced techniques and excellent team members, the services including but not limited to: prescription evaluation/optimization, reference preparation dissolution similarity of different media, types of impurities/belonging, stability studies and guidance on the work of process validation. Finally, a comprehensive report of generics consistency evaluation will be offered for the supplementary application.