Dow Pharmaceutical Sciences

Unmatched Experience with Semi-solid and Liquid FormulationsAt Dow we focus only on semi-solid and liquid product development, so you know your product is in very experienced hands. After 35+ years, we know how to correct or prevent the unique problems that can occur in semi-solid and liquid formulation development, analytical, scale-up and long term storage. In just the past 3 years we helped more than 75 clients develop stable, elegant, scalable formulations that are disease compatible and penetrate the skin as required. Intimate Knowledge of FDA Non-Clinical And Clinical Requirements With so many client products in development, Dow interacts with the FDA on almost a daily basis. Our experienced regulatory professionals have managed over 6 approved New Drug Applications in the last 5 years. Dow provides thoughtful planning that incorporates market assessment, highly successful reformulation, new indications and patent life extension strategies and knowledge of current FDA policies to streamline the product approval process. We submitted one of the first eCTD complaint NDAs to FDA’s Center for Drugs (CDER) and have participated in numerous guidance meetings in a variety of CDER divisions. With over 40 approved INDs in the last 7 years the Dow’s regulatory team has successfully managed a variety of unique and complex CMC, toxicology and clinical challenges.