Once in the hands of your consumers, your product will be stored and used in a variety of unintended ways. That’s why stability testing and storage services are a critical part of our product development process. To help determine your expiration date, have three stability chambers — some are inverted, while others are standing upright. We’ll put your product in the chambers and then pull the samples and test them to ensure they still follow all the parameters filed.
In order to test your product in a timely manner, we’ll accelerate the process — while remaining within the scope of inactive and active ingredients. This helps us determine the appropriate expiration date and ensures that the batch you have will meet government regulations. From cGMP and FDA to ICH, we’ll hold you accountable so that there come no surprises when filing for approvals.
How It Works
PD Partners offers cGMP stability and storage programs for a wide array of products — from BioPharma to consumer products — and helps them meet ICH conditions. Our ICH stability services include long-term, intermediate, and accelerated stability. Our FDA-approved facility meets all requirements and offers a variety of storage conditions, including:
- 25° C/ 60% RH
- 30° C/ 65% RH
- 40° C/ 75% RH
Our Proven Process
- Analysis and discovery
- Testing
- Establishing a sample formula
- Scaling capabilities
- Modification and adjustments
- Labeling and parameter testing
- Finalizing the product
Benefits of Working with PD Partners
- Monitor temperature and humidity for 24-hours
- Meet cGMP, FDA, and ICH requirements
- Avoid expensive stability equipment costs
- Store and stabilize your product in a single facility
The PD Partners Guarantee
Our testing, storage, and stability facilities provide the work you need cost-effectively and professionally. With 15,000 square feet of space, our facilities are pre-approved by the FDA and are licensed as a Class 1 by the DEA — making us one of only 30 locations in the US to provide cannabinoid-containing product testing.
Our commitment to doing right by both you and ourselves ensures that we’ll never cut corners to make your product work. From keeping our facilities compliant with government regulations to helping you get your new product approved, we’re here to help you navigate the complexities of the new product development process.