Impurity Isolation and Structure Elucidation
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
Method Development with HPLC-CAD
EZ Labs Analytical Laboratory Services
Reference Standard Certification
What are Reference Standards?
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
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:
Early Development Stability
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.