He is a proven expert in Regulatory Compliance. This type of program centers on the verification of commitment pharmaceutical companies make to the FDA through drug applications or INDA, NDA, BLA, and ANDA submission documents.   This is done to ensure  that pharmaceutical companies strictly adhere to the commitment they make to the FDA and U.S. government—particularly on the issue of drug safety and efficacy.


 He is an expert in ensuring that, if there changes with the commitments pharmaceuticals companies make to the FDA during drug applications – whether in drug formula, manufacturing process, labeling, or if any change is made on any CMC issues pertaining to the already approved drug products, which might  be an impact Safety and Effectiveness of drug products that such changes are reported to the FDA, and the corresponding drug applications (INDA, NDA, BLA, and ANDA) are updated to reflect such changes in a timely manner.