Who We Are?

Peter Karlton - Principal

Peter created Karlton CMC Consulting to specialize in parmaceutical CMC and Developing World regulatory affairs for the global pharmaceutical industry.

Peter is a widely recognized Lecturer and Author in the areas of pharmaceutical CMC and developing and emerging world regulatory affairs. For the past 30 years, he has focused his career on all phases of CMC regulatory affairs from early phase clinical development through product launch and post-approval support.  He has developed successful CMC registration strategies for 10 products that have been successfully marketed worldwide.  

In addition to his broad experience with pharmaceutical CMC, Peter has a proven track record with registration of NCEs in the developing world. While at Gilead Sciences, he was the architect of an innovative approach to the development of modular dossiers enabling the submission of 200 marketing applications in more than 100 countries in less than 18 months.

Prior to establishing Karlton CMC Consulting, Peter worked in regulatory leadership positions for Johnson & Johnson, Sanofi-Synthelabo, Amgen, Gilead Sciences, and Avigen, Inc. Most recently he was Director of Global Regulatory Affairs, CMC for Gilead Sciences, and Sr. Director of Regulatory Affairs for Avigen, Inc.