Mohan

Ganapathy Mohan, Ph.D

President, Mohan Pharma CMC Consulting LLC

Guest Expert
About

Mohan retired from Merck in 2023 and has worked in the pharmaceutical industry for about 40 years.

At Merck Mohan’s last position was head of Global External Advocacy and prior positions were head of Global Research/Development Quality and head of Global CMC Regulatory Affairs.  

Prior to Joining Merck Mohan’s last position at Sanofi was Associate Vice President of Global Analytical Sciences Department) and he also served as the US head of R&D Quality Assurance.

Mohan served until March 2023 as the US Topic Lead in the ICH Expert Working Group and Implementation Working Group for development of ICH Q13 on Continuous Manufacture of Drug Substances guideline until it was published in December 2022. He led the PhRMA Nitrosamines Task Force until the end of 2022 (represented by nearly 20 global pharmaceutical companies).

He also led the PhRMA Core Team on Accelerated Global Drug Approvals where he has participated in meetings with the FDA and EMA. He has also served in the USP Council of Experts, was Chair of the AAPS Regulatory Sciences section, and Chair of the IQ Consortium’s Quality Coordinating Council.

Mohan has a Ph.D in Analytical Chemistry from Kansas State University.

Expertise & focus areas
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Pediatrics, Nazim Kanji, Orphan Drugs, Rare Diseases

How strong sponsor and CRDMO partnerships help streamline orphan/rare and pediatric drug development

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