Pharmaceutical Development
Early Clinical Development
Clinical Development
About AAIPharma
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About AAIPharma

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We are a global drug development company providing services that span the entire drug development spectrum. Our customers range from virtual to large Pharma and include some of the most notable Pharmaceutical, Biotechnology, and Medical Device companies worldwide. We provide the resources, infrastructure, and expertise to produce, develop, and ultimately register new drug product candidates and support their entry into the market.

 

In our Pharmaceutical Development division, we have expertise in formulation, manufacturing and analytical chemistry with capabilities that include both small molecule and biopharmaceuticals. Our product development know-how enables our customers to bring a pharmaceutically elegant and more importantly, stable dosage form, forward to begin toxicology and subsequent clinical testing. In addition, we provide support in manufacturing, packaging and clinical distribution of both solid dose and sterile dosage forms for clinical studies, as well as manufacturing for commercial products. We constantly strive to meet our customers' needs by providing value added services such as pharmacovigilance, quality management, and regulatory support for marketed products.

 

In our Early Clinical Development division, we consult with our customers seeking to understand the activity profile of their drug product candidates. Equipped with state of the art facilities, exceptional bioanalytical capabilities, and extensive experience with many different molecules and methods, we evaluate the clinical pharmacology, safety, and activity of product candidates in our Phase 1 clinics. We also assist our customers in their investigation of the potential therapeutic use and benefit of their compounds through first in patient studies that we execute at specialized investigator centers worldwide.

 

In our Clinical Development division, we perform large scale Phase II-IV trials to confirm the therapeutic profile of our customers' products and market differentiation in support of worldwide registrations and launches. After launch, we continue to support our customers' products through further clinical testing and exploration of new uses, benefits, indications and therapies.

 

Throughout our almost 30-year history, we have learned to work in close collaboration with our customers' project teams. From single sample testing in our analytical laboratories to conducting global clinical trials, we share the passion and commitment of our customers for their projects. We combine our customer's product innovation with our leading edge processes, know-how and experience to produce exacting results. At AAIPharma, we are focused on steadily improving pharmaceutical R&D productivity. Through all this, we create sustainable value for our stakeholders: our customers, our staff, our communities, and our shareholders.