Product Development Partnership Services
Developing a new product from scratch requires a lot of resources, industry know-how, and scientific expertise to get it done right. From all the particulars involving the development of your product to the minute details of each required government form, there’s a lot to consider. It can be overwhelming, but that’s why PD Partners provides the services you need to eliminate process inefficiencies and produce high-quality medicine.
Far too frequently in our industry, a project or filing is delayed by not focusing on the critical details in planning, formulation, or testing. For years, we’ve been helping dozens of businesses avoid these complications while developing quality products in which they can be proud to provide. Our commitment to excellence ensures we’ll never cut corners, and we’ll do everything in our power to do right by you — and ourselves. Learn more about our services and see how PD Partners can assist your next project.
Our Services
Formulation Development Services
It all begins with an idea — yours. Whether you’re looking to create a new drug from scratch or adjust the formula of an existing drug, we’re here to help. We’ll talk about your ideas and put our team of scientists to the task of delivering your project. We’ve already helped dozens of businesses develop new products — see what PD Partners can do for you.
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Analytical Method Development Services
Once we’ve determined the best route for your product development, then we’ll think through the hundreds of possible scenarios that could impact filing your drug. Whether it’s creating the bottles first or going straight to cups, we’ll determine the best course of action for your product and carry out the plan — helping you get approved sooner.
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Stability Testing & Storage Services
Stability testing equipment can be expensive, but transporting samples to a third-party can be risky. We provide stability testing and storage to ensure your parameters match what has been filed and help you remain in-scope with inactive and active ingredients. Plus, since we test in the same facility where your product is developed, you know it’s in good hands.
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Microbiology Testing Laboratory & Analysis Services
Recently, the FDA has been more mindful of microbiology issues — from the water within your systems to the ingredients in your product. That’s why we have a microbiology testing lab to analyze your drug, test it for any issues, and isolate any problems that occur. With our thorough testing, we’ll eliminate any recall risks and keep your product safe.
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Quality Assurance Consultant & Audit
Avoid the costs of hiring an outside consultant to conduct a mock FDA inspection. With our industry expertise, we’ll inspect your product and determine if it meets cGMP, OCP, and other quality system requirements. Because our facility is pre-approved by the FDA, you can be certain that our tanks are cleaned between each use, and everything is in order for your inspection.
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ANDA Submission Consultant Services
Developing a new product requires metaphorically jumping through hoops. Unless every detail is followed, your entire project can come to a halt. That’s why we provide consulting services to help you file paperwork appropriately and continuously meet ANDA requirements — even if they change. Let PD Partners help you navigate the complexities of file submissions.
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Product Development Consulting Services
From facilitating regulatory strategies to interactions with regulatory authorities, we’ll act as your guide. We’ll connect you with the right people and provide insight on how to prepare for meetings. By identifying quality metrics, we’ll help you continuously improve and adjust to industry best practices — avoiding any inconsistencies or challenges that may interrupt the project.
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