Our Stability Centre is dedicated to support innovator and generic pharmaceutical industries globally. The Centre is located in Waluj, India, is designed to help pharmaceutical companies evaluate the shelf life, storage conditions and overall stability of their products in compliance with global regulatory guidelines.
With a focus on quality, reliability, and regulatory compliance, the Stability Centre serves as a trusted partner in the development and commercialization of pharmaceutical products.
KEY FUNCTIONS:
Stability Study Design & Execution: For new drug development, ongoing process validation, and post-approval changes.
Accelerated and Long-term Stability Testing: To assess product behaviour under different climatic zones.
Photostability Studies: In accordance with ICH Q1B.
Regulatory Support: Provides critical data for dossier submissions (CTD/ANDA/NDA) and life-cycle management.
The Stability Centre is staffed with experienced scientists and analysts trained in GMP and GLP practices. The team ensures that all processes are well-documented and audited regularly for compliance, contributing significantly to product quality assurance and regulatory approval.
INFRASTRUCTURE:
- High Performance Liquid Chromatograph
- Gas Chromatograph
- UV-visible Spectrophotometer
- Karl Fischer
- Dissolution Apparatus
- Walk-in Stability Chambers
- Microbiology Laboratory
- Analytical Laboratory
