We conform to the current guidelines developed
for new drug substances and products by the Expert Working Group of the ICH. Our storage
features include:
Walk-in and reach-in chambers with temperature settings to
meet your needs, ranging from -25°C to 60°C
A variety of humidity settings
A variety of light exposure configurations
All storage conditions fully validated and monitored 24
hours/day
We have a routine calibration and maintenance program for all
chambers and equipment, including thermocouples and chart recorders.
To develop protocols to generate data required to answer
questions arising during development, clinical trial testing and post-marketing phases of
your products.
Our highly capable method development group will develop and
validate stability indicating assays.
Our stability protocol development process conforms to cGMP
requirements. All stability samples are labeled with time and storage condition
information.
Our validation studies are recognized by international
regulatory agencies.
Stability reports are tailored to your requirements and may
include individual test point results, summaries at specified time periods or cumulative
data at each study's conclusion.
