Pharmaceutical companies face increasing challenges in developing new products, improving existing formulations, and bringing drugs to market efficiently. From selecting appropriate dosage forms and optimizing product performance to addressing manufacturing considerations and evolving regulatory requirements, successful development demands scientific expertise and careful planning.
PD Partners works with pharmaceutical manufacturers and generic drug developers to address these challenges throughout the product lifecycle. Our experience includes oral solutions, suspensions, topical formulations, and other pharmaceutical products. We understand the importance of balancing product quality, regulatory requirements, development timelines, and commercial objectives to achieve successful outcomes.
How PD Partners Can Help
With more than 20 years of pharmaceutical industry experience, PD Partners provides practical solutions to complex formulation and development challenges. Our team evaluates active pharmaceutical ingredients (APIs), excipient selection, product stability, and manufacturing considerations to develop scientifically sound strategies tailored to each project.
Our extensive experience preparing and submitting Abbreviated New Drug Applications (ANDAs) provides valuable insight into FDA regulatory expectations. By incorporating these considerations early in development, we help clients address potential obstacles, improve efficiency, and establish a clear path toward regulatory submission and commercialization.
Benefits of Working With PD Partners
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More than 20 years of pharmaceutical development experience
- Leverage expertise in cGMP and ICH requirements
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DEA registered, FDA inspected, and cGMP compliant laboratory
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Extensive experience preparing and submitting ANDAs to the FDA
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Experience with oral solutions, suspensions, and topical dosage forms
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Established laboratory capabilities supporting development and commercial product quality
Created in Our World-Class Facility
Located in Tampa, Florida, PD Partners operates a 15,000-square-foot laboratory within a company-owned, 44,000-square-foot facility, providing significant potential for future expansion. Our DEA registered, FDA inspected, and cGMP compliant operations are supported by established quality systems, experienced scientific personnel, and specialized laboratory equipment.
Our capabilities include pharmaceutical testing in accordance with applicable USP, BP, and EP standards, as well as ICH stability programs supporting product development, shelf-life evaluation, regulatory submissions, and ongoing commercial product quality. These resources allow us to provide reliable scientific support while accommodating the evolving needs of our clients.