Before the FDA conducts its pre-approval inspection, wouldn’t you want to know how well you’ll do? From meeting labeling parameters to satisfying government regulations, the FDA will quality check your products and ensure everything is up to standards. That’s why our pharmaceutical quality assurance consultant and audit services provide a mock FDA inspection to help you prepare for the real deal.
Our inspection focuses on the regulatory and quality of your product — similar to the FDA’s inspection. With our extensive knowledge of government regulations, we can help you check off the boxes for what they’ll be expecting to see. And, we’ll help you make continuous improvements so that you’re always meeting industry best practices and regulations — including the cGMP and OCP. Plus, we’ll make sure everything is validated so that you won’t run into any inspection mishaps. From the tanks we use, down to the spreadsheets and equipment, we’ll keep our processes buttoned-up so that you never have to worry about them.
How It Works
Part of your FDA inspection includes an examination of the facility where your product is made. When your product is created in our lab, you can guarantee that our facilities will pass any government regulations — because they already have. While our FDA-approved facility meets all requirements, you should expect for them to test your product thoroughly, including:
- Expiration date
- Ingredient percentages
- Product parameters and how closely they align with what’s filed
- Contamination risks
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
- Gain peace of mind
- Discover issues before the inspection
- Eliminate costly mistakes
- Satisfy cGMP and ICH requirements
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.