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Breakthrough in global regulatory affairs projects:

FarmavitaR+ Formed as a Strategic Alliance of Regulanet® and Farmavita.Net

Farmavita.Net and regulanet® AG have established FarmavitaR+®, a joint venture company delivering high-quality regulatory affairs services to clients for pharmaceutical projects in Central, Eastern and Southern Europe.

FarmavitaR+ will be headquartered in Samobor, Croatia, and will manage a network of regulatory affairs associates throughout Central, Eastern and Southern Europe. FarmavitaR+ will combine the geographic reach and expertise of Farmavita.Net with the project management and quality standards of regulanet. The new company gives clients the opportunity to have consistent regulatory affairs services throughout all of Europe.

FarmavitaR+ will combine the geographic reach and expertise of Farmavita.Net with the project management and quality standards of regulanet.

Countries covered by FarmavitaR+ are Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Hungary, Macedonia, Montenegro, Romania, Serbia, Slovakia, and Turkey. FarmavitaR+ will also provide services for pharmaceutical companies in these countries who wish to enter into the EU and US markets.

In today’s marketplace, licensed pharmaceuticals are expected to have significant revenues from Day One, and any delay in time to market means a loss in revenue and profit. To effectively deal with this situation, a thorough and comprehensive knowledge of all relevant guidelines, precedents, and competitors, has become mandatory to avoid such delays. Likewise, sophisticated IT tools for networking and communications, CMS, eCTD, eCFR submissions, and project management are a necessity. FarmavitaR+ combines extensive knowledge, global expertise and up-to-date tools with a strong national presence to successfully complete regulatory submissions.

Dr. Jürgen Regenold, Managing Director of regulanet® and Mr. Zdravko Mauko, Director of Farmavita Ltd., stated: “We are pleased to announce the founding of FarmavitaR+ Ltd. We feel strongly that this alliance will benefit clients by giving them better access to the emerging markets of Central, Eastern and Southern Europe. FarmavitaR+ will also benefit pharmaceutical companies from these regions by giving them better access to markets in the EU and USA.”

Farmavita.Net (www.farmavita.net) is the leading pharmaceutical licensing, technology transfer and regulatory affairs network in Central, Eastern and Southern Europe. As a service agent in pharmaceutical business development, licensing and regulatory affairs, the company also manages a virtual marketplace for pharmaceutical Dossiers, know-how and technologies.  Registered members of the Farmavita.Net network have access to a number of solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products.

regulanet (www.regulanet.com) is a network of regulatory affairs agencies with members throughout Europe and in the USA. Founded in 2001, member companies offer services to a wide variety of scientific and pharmaceutical clients from around the world. The network uses state-of-the-art tools to ensure efficient communications and access to information, providing advice and assistance on international projects such as decentralized, mutual recognition and centralized procedures. Members provide clients local representation and customer care for international projects and have experience in all aspects of registration procedures throughout the EU and the USA. The network has been at the forefront of eCTD submissions, including successfully developing and testing submission tools for the past 6 years. regulanet members are trained and certified in accordance with comprehensive Quality Assurance standards based on industry best practices and monitored by independent consultants.

More information about regulanet is available at http://www.regulanet.com

More information about Farmavita Ltd.  is available at http://www.farmavita.net

 

Samobor, 27th September, 2007

For further information, contact:

Mr. Zdravko Mauko,

FARMAVITA Ltd.
Okicka desni odvojak 2
HR-10430 Samobor
Croatia
Tel/Fax: +385/1/3360785
This email address is being protected from spambots. You need JavaScript enabled to view it.

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