Light, humidity, temperature and time can wreak havoc on your product. Stability studies are essential to your path to market by demonstrating your products remain safe and effective during storage, transportation and under varying environmental conditions.
Our dedicated Stability team provides complete and tailored services at all stages for regulated products. This includes early and in-process Research & Development to Post Approval Studies conducted in full compliance of FDA and Health Canada requirements and conforming to current ICH guidelines for new regulated substances and products.
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.
Design and Execution of Accelerated, Real–Time and Stress Stability Testing
Stability Protocol Design
Shelf Life Stability
Accelerated and Intermediate Studies
Stability testing for IND, NDA, ANDA
Formulation Evaluation Stability Testing
Forced Degradation Studies
Freeze & Thaw Study
Formulation Capability Study
Regular Service for routine sample turnaround time is 7- 10 business days.
Rush Service available for 5 day and 2 day turnaround at additional rates.
Regular Service for routine sample turnaround time is 7- 10 business days. Rush Service available for 5 day and 2 day turnaround at additional rates.