Once the path has been determined, and we know what type of product you need to be created, then we can begin thinking through the different use-case scenarios. We’ll help you determine what is needed to file your drug and what steps should be taken first. Whether this is making bottles and adding cups later as an amendment, or finalizing a smaller sample size to accommodate filing parameters, no matter the steps, we’ll navigate them together.
PD Partners makes it easier to file your drug by creating a strategy for the original filing. Our analytical method development services help you discover what needs to get done first, what can be pushed off to later, and what needs to be determined to help file and get approved by the FDA. With our extensive experience, we’ve helped dozens of businesses develop new drugs for the market. Now, let PD Partners help you.
How It Works
Your product needs to meet specific requirements to produce it correctly. In some cases, we may have to cool down before adding an ingredient, then heat up to add another. All of this takes time. And, that’s only a one-gallon sample. Imagine scaling to 2,000-5,000 gallons. Fortunately, you don’t have to imagine it, because we do it for you. Our FDA-approved facility offers the equipment needed to get the job done, including:
- HPLCs – 15 – Waters
- Dissolution apparatus – 5 – Vankel/Distek
- HPLC – MS
- Karl Fischer
Our Proven Process
- Analysis and discovery
- Establishing a sample formula
- Scaling capabilities
- Modification and adjustments
- Labeling and parameter testing
- Finalizing the product
Benefits of Working with PD Partners
- Licensed as a Class 1 facility with the DEA
- Scale products up to 5,000 gallons
- Meet FDA and ANDA compliance
- Avoid costly filing mistakes
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.