KeacGMP

Stability Studies

Stability Studies


At Ficus Realtime, we provide comprehensive Stability Study Services to help pharmaceutical and life sciences companies determine the shelf life, storage conditions, and long-term product integrity of drugs, biologics, and medical products. Our approach combines regulatory expertise, scientific precision, and digital documentation to ensure every product remains safe, effective, and compliant—from development to distribution.

Stability studies are controlled investigations that determine how a product’s quality, potency, and safety change over time under various environmental conditions such as temperature, humidity, and light.
These studies are essential for:
Establishing expiration dates
Recommending optimal storage conditions
Supporting regulatory submissions
Ensuring product performance throughout its lifecycle

Our Material Management Services
Real-Time Stability Studies Simulates long-term storage under recommended conditions to define shelf life accurately.
Accelerated Stability Studies:
Exposes products to elevated stress conditions (e.g., 40°C, 75% RH) to predict long-term behavior more quickly.
Stress Testing:
Identifies degradation pathways under extreme conditions—essential for formulation development and packaging validation.
Photostability Testing:
Assesses product stability under light exposure to determine the need for protective packaging.
In-Use Stability Studies:
Evaluates how products perform after opening, reconstitution, or routine usage.

 

Testimonials