In addition to getting approval from the FDA, there are tons of regulatory strategies that must take place. From connecting to the right authority figures to submitting paperwork and other documents properly, there’s a lot to keep track of. Any errors can result in your project being put on hold — which means more money and time being put into the project. That’s why PD Partners helps guide you through the regulatory process.
Our pharmaceutical product development consulting services lead you through the entire regulatory process — from facilitating interactions with regulatory authorities to preparing documents for submission. No matter where you are in the process, we’ll help you take your project to the finish line. We’ll audit quality systems that are already in place and make sure your processes are up to industry best practices. Plus, we’ll identify quality metrics to ensure you’re continuously improving.
How It Works
We know that having the right processes in place from the beginning can make all the difference for your project. That’s why we’ll design and validate your quality systems to ensure they’re doing everything you need them to do during the project and implement best practices where there are none. For years, we’ve been helping businesses meet a variety of industry regulations. To help you meet yours, we provide consulting services for:
- Approval on drug master files
- Regulatory submissions
- Preparing regulatory documents
- Facilitating regulatory strategies
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
- Avoid costly filing mistakes
- Meet government compliances and regulations
- Leverage a 15,000 square foot FDA-approved facility
- Follow industry best practices
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.