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Since our inception in 1981, we’ve been strengthening our industry relationships and building on our knowledge of the ever-changing United States biopharmaceutical R&D marketplace.
We have a keen understanding of the issues, environments and challenges that are currently driving the industry and, with that in mind, we’ve structured our company to provide excellent delivery of Phase I–IV clinical development and regulatory services to meet your needs. Our project leaders in the United States and abroad are at the heart of project delivery and head a multifunctional team of experts that bring clinical expertise closer to our customers.
We also understand how to meet the challenges of patient recruitment in the United States. Our strong relationships with investigative sites as well as the upfront study feasibility and startup strategies we provide ensure the success of your development program.
Kendle even offers you expert consultation on early planning to prepare your New Chemical Entity, New Molecular Entity or device for the very first phases of clinical development.
To complement our clinical pharmacology services in The Netherlands and support the needs of a growing United States generic pharmaceuticals market, we have a bioequivalence and pharmacokinetics facility located in Morgantown, West Virginia, near the campus of West Virginia University. This dedicated facility has been in operation for more than 20 years. And with bed space for 118 subjects, divided into five quadrants, we can conduct five studies simultaneously and independently.
Our Rockville, Md. office, along with our corporate headquarters in Cincinnati, serve as hubs for our regulatory affairs service in North America. They provide first-hand knowledge of FDA-regulatory policies and procedures as well as complement the company's regulatory hubs in Europe and Australia. In fact, our consultants in Rockville have an average of 25 years of experience working for the FDA and can help guide you through the maze of regulatory complexities
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