Pharmaceutical Alliance, Pharmaceutical Regulatory Services and Dr. Regenold GmbH, Operates on All Continents, Provides Full Spectrum of Regulatory Services

Seamless Regulatory Support in over 80 Countries in All Regions
PRINCETON, N.J. & BADENWEILER, Germany--(Business Wire)--
A strategic cooperative agreement between Pharmaceutical Regulatory Services
Inc., (PRS) of Princeton and German-based Dr. Regenold GmbH expands the reach of
their pharmaceutical regulatory and clinical research services to over 80
countries in the United States, Europe, Australia/New Zealand, Asia, Latin
America and Africa. With the new collaboration, 210 employees and 150 associates
now provide regulatory support of new drug development as well as regulatory
maintenance services of marketed products throughout most of the world,
according to Jurij Petrin, MD, President of PRS, and Jürgen Regenold, Dr. rer.
nat., Managing Director of Dr. Regenold GmbH.

"By broadening our reach with highly trained regulatory affairs specialists in
over 80 countries, we are better able to serve our clients in the
pharmaceutical, biotech and medical devices businesses," said Petrin, a
physician and former Vice President, Intercontinental Regulatory Science at
Bristol-Myers Squibb, where he was responsible for international regulatory
oversight of the company`s pipeline as well as marketed products.

"We bring extensive regulatory experience and presence in all regions of the
world, which we believe is unique for companies of our size. Our business model
enables us to keep overhead low while at the same time our team`s regulatory
expertise in drug development and post-marketing services adds significant value
and understanding of our clients` projects, which competitors may not be able to
match," added Regenold, who graduated in pharmaceutical chemistry, worked in
pharmacological CNS research, the management of pharmaceutical product
development and in regulatory affairs, before founding his own business.

"Every country has different business requirements and different processes to
achieve regulatory approval," Petrin said. "Both partners are drug development
companies with in-house experience in getting regulatory approval to bring a
drug to market and keep it there, one country at a time. We manage and support
the R&D process from preclinical through clinical stages and on to post
marketing and sales, throughout the entire life cycle of the product. In
addition, we serve as regulatory liaisons to business operations including
marketing, sales, legal and public relations."

The alliance`s offerings include all services associated with the regulatory
life cycle management of marketed products, as well as regulatory support of new
drug and generic drug development. The alliance also offers worldwide drug
safety and pharmacovigilance services for products in development, as well as in
the post-marketing phase. Last but not least, both companies often provide
assessments of local medical need and business opportunities around the world.

"Our cooperative agreement is a cost-effective solution for supporting
multinational regulatory projects, maximizing use of existing technical
regulatory expertise and resources on all continents," Regenold said.

Petrin founded PRS in 2000 and Regenold founded Dr. Regenold GmbH in 1994 as
cost effective alternatives to the big pharmaceutical company model, with their
headquarters in Princeton, NJ, and Badenweiler, Germany, respectively. Regenold
founded also "regulanet", a network of independent RA-service providers,
operating under common quality standards and using common submission tools.

"We have significant in-house muscle and capability. We can offer the customer
one point of contact for the spectrum of services and coordinate the services to
be performed via our network-partners/associates. This network allows us to use
local partners to see a drug through to approval in most countries of the
world," said Petrin.

Visit www.pharmregservices.com, www.prs-clinical.com and www.regenold.de. Dr.
Petrin can be reached at 609-497-9694.

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for PRS Inc.
Becky Taylor, 1-908-310-7452
becky@btaylorpa.com
or
for Dr. Regenold GmbH
Dr. Alfons O. von Wunschheim, 41-61-281-41-61
ao.wunschheim@regenold.de

Copyright Business Wire 2009