Ensure Product Safety & Regulatory Compliance

Neopharm offers a comprehensive range of Stability Storage and Testing services to ensure the integrity, quality, and compliance of your products throughout their shelf life.

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Our state-of-the-art facilities provide specialized storage conditions tailored to your specific requirements. With a dedicated team and advanced stability software, we manage your stability programs from start to finish, providing timely reports, interpretations, and recommendations. Our expertise in developing stability study designs ensures compliance with all stability testing requirements. 


Compliance with Regulatory Requirements

Stability testing is a crucial aspect of regulatory compliance in the pharmaceutical, biotechnology, and medical device industries. Our stability storage and testing services help you meet the stringent requirements of regulatory authorities such as the FDA, EMA, and ICH. We ensure that your products undergo rigorous stability studies to demonstrate their stability, shelf life, and performance over time.

Product Integrity and Quality

Stability testing provides critical information about the physical, chemical, and microbiological characteristics of your products under different storage conditions. By monitoring product stability over time, we help you identify potential degradation, impurities, or changes in product quality. This enables you to take proactive measures to maintain product integrity, enhance formulation, and ensure consistent quality for your customers.

Timely Decision-Making

Our dedicated staff and advanced stability software streamline the management of your stability programs. We provide comprehensive support, including study design, sample management, testing, data analysis, and reporting. Our timely reports, interpretations, and recommendations empower you to make informed decisions regarding product release, shelf life, reformulation, and packaging changes.

ICH Stability Conditions

We provide ICH stability conditions which include long-term and short-term testing conditions as well as accelerated stress tests. Our team of experts can help you interpret test results and develop a comprehensive stability program tailored to your product's unique characteristics.

Effective Solution for All Your Stability Testing Needs

  • Environmental conditions for all ICH climatic zones including storage at -20°C, 5°C, 25°C/40%R.H., 25°C/60%R.H., 30°C/65%R.H., 30°C/75%R.H., and 40°C/75%R.H.
  • Qualified and validated chambers with dedicated metrology personnel for regular chamber maintenance to assure continuous peak operating performance.
  • 15,000 cubic feet of storage capacity including backup chambers that are monitored 24hrs/7 days by dedicated stability monitoring software.

Neopharm Answers to Common Questions About Stability Storage and Testing

At Neopharm, we offer specialized storage conditions tailored to your specific needs. These include controlled temperature and humidity chambers, refrigerated and frozen storage, photostability chambers, and custom conditions such as accelerated and stress testing. Our facilities are equipped to simulate a wide range of real-world storage conditions to ensure accurate stability testing.

We have dedicated staff and specifically designed stability software to manage stability programs efficiently. Our team oversees the entire process, from study design and sample storage to testing and data analysis. We provide timely reports that include comprehensive interpretations of the data, highlighting any trends or changes, and offering recommendations based on industry best practices.

Absolutely! Our experienced team can help you develop stability study designs tailored to meet all the necessary stability testing requirements. We consider factors such as the product's intended use, storage conditions, and regulatory guidelines to ensure the design aligns with your specific needs. Our goal is to conduct stability testing that provides reliable data to support product quality and regulatory compliance.

The duration of stability studies depends on several factors, including the product type, regulatory requirements, and intended shelf life. Typically, stability studies span different time points, such as 3 months, 6 months, 1 year, and long-term stability (2 to 5 years). Our team will work with you to determine the appropriate study duration based on the specific characteristics of your product and industry guidelines.

Ensure product integrity, compliance, and informed decision-making with Neopharm's reliable Stability Storage and Testing services. With our full range of stability testing and storage capabilities, customized storage conditions, dedicated staff, and advanced stability software, we provide comprehensive management of your stability programs. Contact us today to discuss your stability testing needs and partner with us for accurate, timely, and compliant stability studies.

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