Premier Research Announces Milestone Investigational New Drug Application
PHILADELPHIA, April 7 /PRNewswire/ -- Premier Research Group Limited, the international pharmaceutical services company, is pleased to announce that it has submitted an Investigational New Drug Application which represents the 50th IND under management. The milestone IND was submitted to the FDA's Division of Anesthesia, Analgesia and Rheumatology Products (DAARP), and is intended to support the clinical development of a novel formulation of a non-steroidal anti-inflammatory drug for the treatment of pain.
"This submission to DAARP expands our considerable experience in CDER Divisions and supports a development program for a new drug as a 505(b)(2) NDA, a strategy used by many small to mid-sized biopharmaceutical companies", noted James Ottinger, Vice President, Global Consulting and Compliance.
Premier Research acquired its U.S. regulatory affairs capabilities in 2006 in order to provide regulatory consulting to its U.S. and Internationally-based clients.
About Premier Research
Premier Research is a leading global solutions-driven CRO committed to therapeutic focus and operational expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies. They are leaders in clinical research for analgesia, CNS, oncology, and infectious disease and have a wealth of experience in medical device and pediatric research.
Premier Research has 32 offices and operates in more than 30 countries across North America and Europe employing more 1,200 clinical professionals dedicated first and foremost to fulfilling each client's requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific and medical experts, and staff at our well-established network of dedicated clinical sites.
www.premier-research.com
CONTACT: Jessica Barag, +1-215-282-5391,
jessica.barag@premier-research.com
Web site: http://www.premier-research.com//