Contract Research Organization Services | CRO
We specialize in complex drug product development.
Our contract research organization services include
- Analytical method development (small molecules, biologics) by HPLC, UPLC
- Analytical method qualification (cGLP)
- API Characterization (XRPD, solubility, log P, forced degradation, NMR, FTIR, DSC, TGA, SEM)
- Preformulation and compatibility studies
- Formulation development
- Nanocrystalline formulations
- Emulsion, dispersion, liposomal formulations
- Sustained Release Injectable Microspheres
- Lipid Nanoparticles
- Process Development and Scale up
- Drug Binding studies
- Container Closure studies
- Syringeability studies
- cGLP ICH Stability Studies
- USP IV Flow-through IVRT studies
- Particle Size Distribution (PSD), Laser Light Diffraction
- Particle Sizing by Dynamic Light Scattering
- Surface Tensiometry, Contact angle measurement
- Osmometry
- Moisture analysis by Karl Fisher
- Rheology (Viscometry)
- pH measurement
- Residual Solvent Analysis by GC
- Toxicology clean supplies and cGLP release testing
- cGLP dose analysis
- Bioanalytical method development
- Analysis of API in tissues by bioanalytical LC/MS/MS
- Scale-up and Technology Transfer
Route Expertise
20+ Years in Ophthalmic Delivery from Concept, Pre-clinical to Phase II
Analysis
Method Development and Qualification, Stability Studies, Size Exclusion Chromatography, Thermal Characterization, Particle Sizing
Dosage forms
creams, suspensions, solutions, gels, liposomes, hydrogels, emulsions, microspheres, nanocrystals, microparticles
Molecules
Proteins, peptides, nucleic acids, small molecules (hydrophobic and hydrophilic)
CRO Facilities & Equipment
- R&D labs in operation since 2011;
- cGLP compliant in 2018;
- 10,000 square feet of office/lab space
23 Crosby Drive,
Suite 100A,
Bedford, MA 01730
50+ Years of Combined Experience
Our scientific staff operate with the highest standards of integrity, quality, excellence, and safety with the ultimate goal of doing good science.
CEO Shikha Barman, PhD has 27 years of experience in drug development with numerous patents and publications in drug delivery, biomaterials and gene delivery. She was inducted as a Fellow in 2021 from AIMBE for her contributions to drug delivery. Dr Barman’s background spans ophthalmic, injectable (IM), dermal ( sublingual and targeted therapies). She was featured in C&EN, ACS in April, 2013 issue as one of four women entrepreneurs to watch, and a Technology Showcase winner in 2015 in CRO/CMO, Boston, MA.
COO and Company IP Attorney Dave Karasic is Integral’s first investor. He brings 35 years of engineering, IP and legal experience to the company
Why Choose Integral BioSystems CRO Services
- trusted by bio-pharma companies big and small
- top-notch team with commitment to quality, integrity, safety and excellence
- state-of-the-art cGLP-compliant facilities / equipment
- competitive prices
- fast turnaround
- woman-owned business
Some of Our Amazing Customers
