CRO Services

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
anatomy of the eye
lab-instruments

Analysis

Method Development and Qualification, Stability Studies, Size Exclusion Chromatography, Thermal Characterization, Particle Sizing

Drug crystals

Dosage forms

creams, suspensions, solutions, gels, liposomes, hydrogels, emulsions, microspheres, nanocrystals, microparticles

protein

Molecules

Proteins, peptides, nucleic acids, small molecules (hydrophobic and hydrophilic)

CRO Facilities & Equipment

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

founders

Why Choose Integral BioSystems CRO Services

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Some of Our Amazing Customers

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What Clients Say About Our CRO Services

Integral has provided outstanding support in formulation evaluation and development, always taking into account the particulars of our drug candidate, stage of development, and target indications.
Henry Hsu
MD, CEO, Allysta Pharmaceuticals, CA
They are very approachable and creative to bring you solutions with complete candor on what can or cannot be achieved. They also work with you to ensure that your timelines and budget needs are met.
Sevgi Gurkan
MD, Founder and CEO, Perfuse Therapeutics, CA
Integral has provided outstanding support in formulation evaluation and development, always taking into account the particulars of our drug candidate, stage of development, and target indications.
Bruce Cao
Director, CMC, FHI 360 Jennifer Ayres, Director, Pharmaceutical Development, FHI 360

Accelerate Your Drug Development With
Our Expert CRO Services