Premier Research Announces Milestone Investigational New Drug Application

* Reuters is not responsible for the content in this press release.

Tue Apr 7, 2009 9:30am EDT

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

SOURCE  Premier Research Group Limited

Jessica Barag, +1-215-282-5391, jessica.barag@premier-research.com
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.