Based on international guidelines (ICH, FDA and WHO) stability studies have to be performed on drug substances (DS) and drug products (DP) in order to guarantee quality and efficacy during whole life cycle. Stability testing encompasses all phases of the drug development process, but is also required for the registration phase and beyond to show consistent quality. Our stability studies for pharmaceuticals help you to measure and document time relevant changes to the quality, safety and efficacy of drug products and drug substances.
We can help you:
As a world-leading provider of testing, certification, verification and inspection services, we offer you unrivaled expertise in providing stability studies for the pharmaceutical industry. We provide the flexibility to accommodate your specific protocols, supporting bracketing and matrixing, specified time-points, sample configurations and sample amounts as well as other international requirements. We can also set up specific storage conditions and site conditions as described in guidelines.
Our state-of-the-art procedures are established worldwide, following GMP requirements. Storage conditions, such as temperatures (and humidity when controlled) are continuously monitored by our facilities monitoring system. All chamber thermistors, thermocouples, humidity sensors, and radiometers/lux meters are calibrated and traceable to international standards.
We offer tailored solutions for your needs with high-flexibility and adherence to stability testing guidelines within a wide variety of projects and circumstances.
To discuss your stability study requirements, contact us today.
2nd Floor Alegria Office Building. 2229 Chino Roces Avenue,
1223,
Makati, Metro Manila, Philippines