Hi, myself Mr. Chetan Patel, working in reputed US based pharmaceuticals company.
Experienced in strategic regulatory submission in US, EU & ROW and co ordinations with API suppliers.
Having more than 20 years of rich pharmaceuticals industrial experience, combined with regulatory affairs, Medicinal discovery, Drug substance developments labs and Pilot plant with core competency in Regulatory affairs.

Expertise in evaluation and making control strategy of genotoxic impurities as well as N-nitrosamine impurities as per the ICH M7 guideline and current authorities’ expectations.