Strategic Regulatory Consulting for Accelerated Global Compliance

Stability Studies


At FicusRealtime, 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.

 

Industries We Serve

Industry-Specific Software for Enhanced Quality and Compliance

Pharma
Advancing healthcare through pharmaceutical innovations.
Engineering
Precision engineering solutions for industrial applications.
Excipients
Quality excipients for enhanced pharmaceutical formulations.
Formulations
Innovative drug formulations for effective treatments.
Biologicals
Advanced biological solutions for medical and research use.
Biotechnologicals
Cutting-edge biotechnological applications for various industries.
CRO/CDMO
Contract research and manufacturing for pharma industries.
Aquatic/Poultry
Innovative healthcare solutions for aquaculture and poultry.
Agro Based
Sustainable agro-based solutions for farming industries.
Biotherapeutics
Targeted therapies for enhanced healthcare solutions.
Aquatic Medical Devices
Medical advancements for aquatic life healthcare.
Cosmetics
Beauty and skincare innovations for enhanced personal care.
Polymers
Advanced polymer solutions for diverse industries.
Agro Chemicals
Sustainable agro-chemical solutions for modern farming.
Special Chemicals
Innovative chemical solutions for industrial applications.
Drug Pellets
Revolutionary drug pellet formulations for improved delivery.
Nano Technology
Advanced nano-technology solutions for various sectors.

Testimonials

20K+ Satisfied Clients World Wide