About us

Company Vision and Business Model

Who We Are

We are a drug delivery company developing complex dosage forms.
Founded in 2009 and fully operational in 2011, Integral BioSystems is situated in 10,000 square feet of customized laboratory and office space at 23 Crosby Road, Suite 100A, Bedford, MA 01730. We are a fully outfitted development and process engineering laboratory with an established Quality policy. We have a quality system that can address both R&D and cGLP activities. Thus, we can be nimble and flexible performing R&D exploratory and early development of dosage forms, as well as establish a well-documented program for cGLP studies. 

What We Do

Our expertise is in drug delivery, in the development of biocompatible formulations that are compatible with physiological fluids and tissues.
We have expertise in ophthalmic, oral, sublingual, intranasal, inhalation, otic, rectal, vaginal, IV/IM 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.

Delivery systems are customized to achieve sustained release or targeted, tissue-focused delivery or fast-release/instant delivery, depending upon the desired product attributes. We scale-up our formulations to process engineering principles to develop process controls. We work with start-ups, small companies and large pharma, whether it is to manage and develop the program from “soup-to-nuts”, or take on projects to be an “extended R&D arm” for an established company. 

Specific Expertise

We have specific expertise in ophthalmic drug delivery, known as one of a handful of CROs working in the field. We have worked on both back-of-the-eye and front-of-the-eye indications.
Additionally, we are experts in injectables, whether these are injections, infusions and sustained release. We are experts in microencapsulate- and nanocrystal-based delivery systems, taking the API from analytical development, preformulation and formulation prototype development.

Hybrid Business Model

We have established our credibility in industry as a top-notch CRO (fee-for-service). In addition, we have an out-licensing model. We have two proprietary drug delivery systems that can be evaluated with your API for improved performance (NanoM™, OcuSurf™)

Our Mission

Integral BioSystems mission as a Contract Research Organization (CRO) is to provide quality, high-end R&D and cGLP technical services in specialty formulation development services for a variety of dosage forms. 
In our mission to “Innovate to Improve”, we have developed and patented two proprietary platform delivery systems that can be applied with various APIs, routes and indications. 
We have developed the OcuHeal™ technology, developed for bioavailability enhancement. We have developed the NanoM™ technology to provide sustained release technologies for use in ophthalmology, urology and other tissue types. These technologies are patented, and are available for licensing for development with your API. 

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