Stability studies
Ludof Pharmaceutical Ltd offers reliable cGMP stability testing services. We can remove the time and resource burden of ICH stability testing, whether you are a big pharma company that prefers to use external resources, or a small R&D team without the laboratory facilities or technical expertise required.
We deliver everything including sample receipt, shipment and reporting from a single GMP approved facility. Our centre of excellence for stability study services has been operating to the highest quality standards since 1987 while still delivering a cost-effective service.
Our team of more than 85 experienced scientists can provide numerous stability study services, including:
- Logistics including sample transportation and import requirements
- Long-term drug ICH stability studies
- Accelerated ICH stability studies
- Shelf-life assessment
- In-use studies
- Short-term temperature excursion studies
- Restricted access control, stability storage rooms set as per ICH stability conditions
- Forced degradation and photostability studies for developing stability indicating methods and to understand the nature of molecules
- Stability chambers are available at conditions to cater for all climatic zones as per ICH guidelines (ICH Q5C and ICH Q1B)
- Freeze-thaw & temperature cycling
- Support for schedules II, IIIN, and IV controlled substances
- State-of-the-art analytical capabilities including microbiology testing
- Impurity identification and qualification
- Execution of protocol, data analysis and final report
Our customers use our stability studies services for a number of reasons, including:
Flexibility
We provide flexible solutions to suit all types of customers, including fee per sample analysis, fee per hour, a FTE programme and dedicated analytical testing laboratories.
Quality
Thanks to our quality culture and strong track record spanning over the years, you can trust us with your stability studies. Our facility is EU QP approved and has been FDA inspected in 2012, 2015 and 2017 with no critical or major issues.
Cost
Our location provides cost advantages without compromising quality standards.