Incorporated in 2019, Sancilio and Company is wholly owned by Dr. and Mrs. Sancilio. Offices of the firm are in Stuart, Florida. Sancilio and Company has three lines of businesses: Clearway Global operates as a pharmaceutical research & development service through a network of associates that span the entire development process from discovery through clinical trials; Omega Blu, a company which sells high quality nutritional products; and Altemia, a medical food company, with products developed for the dietary management of sickle cell disease. At present, Sancilio is involved in the management of several NDA programs at various stages of development. We are actively engaged in sourcing API from global manufacturers, designing regulatory strategies for new and existing drugs, project managing the creation of CMC packages for NDA submissions and developing clinical research programs for eventual submission to the US FDA. More recently, we've began working with global CROs to design pathways to approval external to the United States. Hence, we are meeting with regulators in Japan and elsewhere to design parallel international regulatory strategies. We have been operating our contract development business as "Clearway Global" for the past 2 years and recently incorporated Sancilio and Company, Inc. to manage the internal research programs and product offerings. The former company using a similar name (Sancilio Pharmaceutical Company, Inc.) was founded by the Sancilio family in 2005. Following a change of control in 2017, the Sancilio family departed and operations and management was reorganized. Eventually assets of the former company were sold to several acquirers and remaining operations were terminated. The new Sancilio and Company, is sponsoring its own development work in fatty acid research, improved bio-availability of lipids and applications of essential fatty acids to treat disease.
