Integral BioSystems specializes in formulation development, analytical method development and scale-up /technology transfer of ophthalmics, dermals, injectables, otics, pulmonary, intranasal and rectal dose forms. The company offers sustained release drug development expertise and know-how including injectable microspheres, liposomes, hydrogels, nano-complexes and micro/nanocrystals.

Additional services include GLP formulations for toxicology supplies and non-GLP bioanalytical analyses. Additionally, the company offers licensable, patent-protected delivery systems (OcuHeal™ and NanoM™) for 505b2 products. Integral BioSystems has built a significant track record since the beginning of its founding in 2009, and has established credibility in the pharmaceutical industry. To date, Integral has developed complex formulations and dosage forms for small molecules, proteins, peptides, nucleic acids and small molecules. Integral BioSystems, LLC is housed in a 10,000 square feet state-of-the-art facility, which includes laboratory and office space in Bedford, MA.

KEY WORDS VERSION 2025

Formulation Development

Drug Delivery

Analytical Method Development

Method Transfer

Analytical Method Qualification

Microencapsulation

Microspheres

Sustained Release delivery systems

Licensable Technologies

505b2

ANDA

Injectable drug delivery

Rectal Formulation Development

Ophthalmic Formulation Development

Sublingual Formulations

Buccal delivery

Otic delivery

Inhalation delivery

Dermal delivery

Intranasal drug delivery

Bioavailability enhancement

In-vitro release testing (IVRT)

Corneal Permeability

Scleral Permeability

Dissolution testing

PLG Microspheres

Biodegradable microspheres

Particle Sizing

Nanocrystals

Nanocrystallization

Suspension formulations

Emulsions

Liposomes

Small molecule formulations

Peptide drug delivery

Protein drug delivery

DNA delivery

Gene delivery

Self-emulsifying delivery systems

Preformulation

Compatibility testing

Method qualification

Toxicology supplies