Our lab delivers ISO/ASTM device testing, ICH stability, and analytical services under one roof — the objective evidence your submission requires.
Objective evidence your submission needs.
We develop protocols and execute functional and performance testing that proves each design output meets its input, with statistically justified sample sizes and pre-defined acceptance criteria.
The shelf-life data your label depends on.
Long-term, accelerated, and intermediate stability studies under controlled ICH conditions establish shelf life and storage claims for your device and combination product.
Developing, validating, and transferring functional test methods so data is accurate, reproducible, and comparable across sites.
Performance testing of delivery devices — e.g., dose accuracy, break-loose force, extrusion force, dose-dial torque, and cap pull-off force.
Accelerated and real-time aging, temperature and humidity cycling, chemical-agent exposure, and simulated-distribution (shipping) conditioning.
Verifying the sterile barrier and closure integrity of your container-closure system, with methods aligned to USP <1207>.
Risk-based biological evaluation of patient-contacting materials to ISO 10993 — from a Biological Evaluation Plan through the appropriate endpoints. E&L study design and interpretation to ISO 10993-17, 10993-18 and USP <1663>/<1664>, characterizing what migrates from materials into the drug product.
Structured investigation of out-of-specification results and field complaints — determining root cause and feeding corrective action.
Let's scope the testing program that will support your combination-product submission.
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