Integral BioSystems is based in the Boston area, with offices at 19A Crosby Drive, Bedford, MA. Integral BioSystems is a contract research organization (CRO) that offers an integrated, practical approach to formulation development projects for both small molecule and large molecule drug candidates. Our business model is based on the following corporate objectives: (a) to be a collaborating partner in formulation development / drug product design for start-up and small companies, taking concepts from the laboratory to the clinic, (b) to re-formulate approved drugs for better efficacy and safety profiles, (c) to be a collaborating partner with API synthesis companies to develop generic drug product formats and (d) offer corporate legal services such as contract development/ negotiations, patent filings and assessment of IP portfolios. Integral BioSystems’ niche is in drug delivery, in the development of biocompatible formulations that are compatible with physiological fluids and tissues. We have developed formulations in ophthalmic, oral, sublingual, intranasal, IV and transdermal routes. Integral BioSystems has a translational medicinal approach to drug development, customizing delivery systems to accomplish the biologically effective objectives of the therapy. From this perspective, delivery systems are customized to achieve sustained release or targeted, tissue-focused delivery or fast-release/instant delivery, depending upon the desired product attributes. Once the drug-containing formulations are tested in preclinical models, we develop an integrated CMC plan to systematically transition the project to scale up and product development. As part of product development, Integral BioSystems specializes in efficiently developing a dosage form to manufacture and test in Phase I/Phase II first-in-man trials for proof-of-concept. We have a network of manufacturers / analytical houses for pharmaceutics, that can fast-track the manufacture and release of the sterile dosage form for first-in-man trials.