Supporting the release of
life-enhancing products to market
Product stability is important to determine shelf-life, the duration for which the product is effective and safe for use. A longer shelf-life is beneficial for managing the supply chain and is often preferred by consumers.
We work with clients to support their product stability requirements from business continuity and storage only to full study management to support the life cycle of medicinal and drug products from development through to post market compliance.
Stability storage is provided in dedicated purpose built walk-in climatic chambers located in a controlled area. The chambers are controlled via a fully validated data management system in accordance with FDA requirements and ICH harmonized guidelines for stability testing of new drug products and substances. Each chamber is temperature and humidity controlled to +/-2°C and +/-5%RH of its target conditions, with 24hr monitoring of chamber conditions.
We are experienced in offering stability services across the following subject areas:
We also work with clients who have storage only requirements. They may need a special condition for which they don’t have the capacity, or they simply don’t have the space or budget to house their own stability chambers. We can pull and ship in the same day, accommodate next day delivery, and we can also accommodate controlled shipping conditions.
Our team of scientific and regulatory experts, backed by our well-established analytical capabilities, understand your specific challenges and opportunities and are committed to working with you to bring life-enhancing healthcare products to market.