Analytical Services for Pharma & Biotech

Impurity Isolation and Structure Elucidation

     Isolation Strategies

     LC-MS, NMR and LC-HR/MS Data Acquisition & Interpretation

     Derivation of the Structural Formula

Method Development and Forced Degradation

     Rationale for HPLC Method Development for the API Release

     Forced Degradation and Understanding of the Degradation Pathway

      Chiral Separations

     Method Development with HPLC-CAD

EZ Labs Analytical Laboratory Services

Method Validation & Verification

     Method Validation

     Method Verification

     Method Transfe

Reference Standard Certification

     What are Reference Standards?

     Retention Markers

     Quantitative Reference Standards

     Characterization of Reference Standards

ICH Stability Studies

     Stability Studies: GMP and non-GMP

     Stability Chambers Set to ICH Conditions

     Color-Coding for Accuracy

     ICH Guideline Test Intervals

     Stability Study Quality Attributes

     Stability Study Analysis & Reporting

Our Mission...

To offer the most efficient approach to

Analytical Development and QC

with scientifically sound and stage appropriate

strategies that meet all regulatory requirements.

Key reasons to choose EZ Labs

          Concierge analytical services provided by experts with immaculate scientific reputation in the industry and strong leadership

          Services are tailored to startup / virtual companies that do not have internal analytical lab or analytical expertise

          EZ labs will become your analytical lab.  You could visit the lab to observe testing anytime

          Problem solving and troubleshooting on the spot with no time wasted

          Track record in all aspects of CMC analytical sciences for drug development

          Strategically driven and stage appropriate project management

          Flexibility, efficiency, responsiveness combined with high quality and integrity of work

          Cost competitive

          One-stop solution – Strategic partnership with other CROs.

Studies in Support of Formulation Development

EZ Labs performs the following studies in support of all stages of formulation development process:

     Excipient Compatibility

     Solubility Screening

     Early Development Stability

     Photostability Studies

     Thermal Cycling and Freeze-Thaw Studies

EZ Labs, LLC is a concierge organization, providing CMC analytical, consulting, and advisory laboratory services to pharmaceutical companies doing small molecule clinical drug development from early pre-IND stage to NDA filing.

EZ Labs is equipped to serve small and medium size pharma companies with growing business opportunities who want to mitigate the risk of building their own analytical capabilities and who may have limited specific internal analytical expertise.

EZ Labs strategically partners with other CROs specializing in material science/pre-formulation and in GMP analytical services enabling us to offer a comprehensive one-stop analytical development solution.