John F. Ameling

Vice President of Regulatory Affairs & Founder

Mr. Ameling has over 32 years of experience in regulatory affairs.  As a regulatory affairs professional, John has successfully prosecuted 5 NDAs and submitted over 40 INDs to the FDA.  Mr. Ameling has coordinated over 125 meetings with the FDA, presented to FDA Advisory Committees, been and “expert witness” in several lawsuits and testified before the US Congress.  John spent 34 years with Procter and Gamble as a regulatory executive and was recognized for numerous achievements and awards. Mr. Ameling won an Outstanding Achievement Award from the Regulatory Affairs Professional Society for serving as Chairman of the Education Committee.  While performing duties as Charleston’s Vice President of Regulatory Affairs, John has lead all communications with the FDA and directed Charleston’s regulatory strategy for the company’s novel pipeline of products. John has also been in charge of contract manufacturing where he has utilized his experience as a Principal Scientist at Proctor & Gamble.  Prior to joining Charleston Laboratories, Inc, Mr. Ameling was the Founder and President of Regulatory Affairs Partners, LLC where he consulted with numerous domestic and foreign pharmaceutical companies.  Mr. Ameling holds a BS in Psychology from the University of Cincinnati.