Charleston Laboratories, Inc, an emerging specialty pharmaceutical company dedicated to reducing opioid induced nausea and vomiting (OINV) in opioid pharmaceuticals, announced today the appointment of John F. Ameling as Executive V.P of Regulatory. Mr. Ameling is the President of Ameling Regulatory Solutions, a consulting company providing regulatory expertise for drug development programs, Pre-IND meetings, IND’s and other numerous FDA interactions.
“I am very fortunate to have someone so dedicated, experienced and top notch as John Ameling to serve as Charleston’s Executive V.P. of Regulatory” said Paul Bosse, Chief Executive Officer of Charleston. “I have been counting down the days to make John an official part of the Charleston team because he has worked so hard and exclusively with me for an extended period of time. The addition of John Ameling’s regulatory expertise expedites the commercialization strategy for our drug candidates. His past interactions and ongoing communications with the FDA have enabled John to remain on the cutting edge of regulatory strategies and trends.”
Mr. Ameling has successfully prosecuted five NDAs and over forty Investigational New Drug applications (INDs). In his role as a regulatory affairs professional, John has coordinated over 125 meetings with the FDA, presented to Advisory Committees, testified in lawsuits as an expert witness, and testified before Congress. John received numerous awards from his former employer of 34 years, Procter & Gamble, where he served a leadership role in Regulatory Affairs. He has been a professional consultant to the pharmaceutical industry for several years.
“Working with Paul Bosse and Charleston laboratories continues to be one of the greatest experiences in my career. I am professionally excited about developing needed therapies that not only treat pain but also eliminate side effects. I feel a keen sense of contribution when considering that patients will benefit greatly from this much needed therapy. The additional benefit to me is the opportunity to work with such committed and totally focused individual as Paul.”