Xxx Xxxxx Xxxxxxxxxx

Biography

Dr. Xxxxx Xxxxxxxxxx is the Principal and Managing Partner of XXXXX XXX, with over two decades of experience in the pharmaceutical industry. Dr. Xxxxxxxxxx has contributed to the development of numerous new drugs and generics, and has worked closely with the XXX on complex xxxxxxxxx and generic applications. Xxx played a key role in establishing the XXXxx division for drug master file reviews under XXXXX, and was instrumental in drafting guidance documents for the XXX, including those on Xxxx XX XXX XXXx xxx xxx XxXxXXX xxx XXXXx. As an expert in impurities in drug substances and products, including nitrosamines, Dr. Xxxxxxxxxx supports the industry in addressing these potential carcinogens by collaborating with organizations such as the Xxxxxxxxxxxxx Xxxxxxxx xxx Xxxxxxxxxx Xxxxxxxxx Xxxxxxxxxxx xXXXXx to create standards for controlling those impurities.