Integral BioSystems LLC
23 Crosby Drive, Suite 100A
Bedford, MA 01730
T: (781) 258-4039 (direct line)
T: (781) 275-8059 (general)


Integral BioSystems is a Bedford, MA-based CRO specializing in formulation development, analytical methods, scale-up, and technology transfer of ophthalmics, dermals, injectables, otics, pulmonary, sublinguals, etc. With state-of-the-art formulation and analytical equipment and expert staff, the company excels at sustained-release drug products, including injectable microspheres, liposomes, hydrogels, nano-complexes, and micro/nanocrystals.

With greater than 75+ years of combined pharmaceutical drug development expertise, Integral BioSystems has built a significant track record since the beginning of its operations in 2011. To date, Integral has developed complex formulations and dosage forms for small molecules, proteins, peptides, nucleic acids, and small molecules. As a CRO, Integral BioSystems offers pharmaceutical companies formulation development services, process engineering, scale-up, technical transfer, and CMC writing services for FDA submissions. Integral BioSystems, LLC is based in the Boston area, with offices and fully equipped laboratories at Bedford, MA.

Operating on a hybrid business model of both fee-for-service (CRO) and innovation (offering patent-protected licensable technologies for 505b2), Integral has focused on the most complex of delivery challenges in ophthalmic and injectable dose formats. As fee-for-service, Integral offers both R&D and GLP services in to the pharmaceutical industry, and is nimble in its delivery timelines. Additionally, Integral offers R&D bioanalytical services for early stage pharmacokinetics studies and GLP services when formulations for toxicology are needed.

Integral BioSystems invites collaborations that can be strictly on a CRO-basis to create drug products with compounds that already have IP protection, or as a co-developer with pharmaceutical companies to render repurposed drugs IP-protectable with Integral’s proprietary drug delivery innovations.

As an innovation company, Integral scientists have developed and patented two delivery systems: OcuSurfTM and NanoMTM.

OcuSurfTM is a proprietary nanostructured, bioavailability-enhancing eyedrop-based platform delivery system, designed to deliver drugs to the ocular surface, enhancing permeation into ocular tissues.

NanoMTM is wafer-based ocular insert, releasing precise, predictable concentrations of drug over time. The composition of the NanoM delivery system can be modulated for a drug regimen that lasts a week, to one that can be designed to last multiple weeks. The company is in active collaborations with multiple drug companies to co-develop ophthalmic products utilizing these delivery modalities. Integral invites questions for future collaborations and opportunities.