Our Business

Karlton CMC Consulting is a "hands-on" pharmaceutical CMC consultancy committed to working with your R&D, pharmaceutical manufacturing, pharmaceutical regulatory affairs, project teams, and business affiliates to create successful strategies and solutions for your CMC and developing and emerging world regulatory affairs goals. 

In addition, we offer highly specialized and focused pharmaceutical regulatory consulting services writing post approval supplements, IND amendments, quality target product profiles, quality SOPs, and a wide range of other CMC and developing world dossiers.  

Peter Karlton has more than 30 years of experience  writing creative and successful CMC pharmaceutical regulatory affairs dossiers during all phases of product life cycle from early development through post-approval support. Our consulting services provide experienced leadership in preparing for meetings with FDA and other pharmaceutical regulatory agencies, and identifying key selling points for your investigational and marketing applications. The goal of Karlton CMC Consulting is to provide direction and hands on experience fashioning a CMC "Brand Image" that will help ensure a timely review of your original CMC regulatory dossiers as well as CMC amendments and supplements, and regulatory meeting background packages