Year Founded: 2009
Number of Employees: 11
Approximate Annual Revenues: $2m–$5m
Key Personnel: Shikha P. Barman, Ph.D.
Chief Executive Officer and Chief Technology Officer
Dave Karasic, Esq.
Chief Operating Officer and Legal Counsel
Integral BioSystems is a drug delivery CRO that offers an
integrated, practical approach to formulation development
projects for both small molecule and biologic actives. The
company’s expertise is focused on sustained release microsphere/
nanosphere development, liposomes, nano/microsuspensions
and lyophilized products for IM, SQ, ocular, otic, dermal and
The company’s business approach is based on providing quality,
top-notch formulation development services to start-ups, virtual,
small companies to assist taking concepts from the bench-top to
technology transfer to GMP facilities. Additionally, the company
has solidified relationships with large generic companies both in
the U.S. and internationally, to develop complex-to-formulate
Integral BioSystems is experienced working with all types of
drug development entities in the US and around the world.
Whether the client organization is a virtual business with no lab
facilities of its own headed by a sole proprietor, an established
pharmaceutical company with extensive development facilities
and staff, or anything in between, Integral BioSystems can help
to minimize development time to speed your drug to market.
Integral provides “soup-to-nuts” assistance in complex drug
delivery projects, especially in product development of sustained
release microspheres/nanospheres, depots, liposomes and
cyclodextrin-based products. For all products, Integral adheres
to QbD principles, required by the FDA for pharmaceutical
products. Integral has developed relationships with GMP product
manufacturers to tech-transfer its processes.
In addition to complete pharmaceutical formulation development
project planning and execution, Integral BioSystems offers
individual, rapid testing that includes NMR, UV-Vis, FTIR,
microscopy, DSC-TGA, particle sizing, Log P, pH, SEM, XRPD,
osmolality, Karl Fisher, volatiles by GC, and dose verification
and viscometry. Additionally, Integral performs deformulation of
generics, permeability testing, dissolution studies, and stability
testing of prototypes.
Integral BioSystems, LLC
23 Crosby Drive, Suite 100A
Bedford, MA 01730