Business Case: Pharma-Bio Serv

Business Case: Pharma-Bio Serv Organization: Industry: Interviewed: Web page: Introduction Founded in February 1993, by Elizabeth Plaza, Pharma-Bio Serv was established as a professional service company that offered technical services, process validation, cleaning validation, product and process transfers, process optimization, and quality and regulatory compliance programs to the pharmaceutical industry. Currently Pharma-Bio Serv employs over 300 biopharmaceutical and medical technology professionals with in-depth experience and committed to fulltime top quality services to our customers, 60 out of these 300 professionals are based in Europe. The companys mission is to resolve its customers professional resources constraints to meet compliance objectives in alignment with regulatory agencies requirements. The company currently provides cGMP (current Good Manufacturing Practice) compliance, commissioning, process engineering, validation, technology transfer, laboratory testing and training services to pharmaceutical, medical devices, consumer, chemical and biotechnology industries in US, Latin America and Europe. Pharma-Bio Serv has completed significant achievements and is positioned to compete at a global level. Pharma-Bio Serv (PBSV) became a US public corporation on January, 2006. The corporation built a Scientific Microbiology and Chemical Testing laboratory in PR, Scienza Labs to expand its services to customers. The lab got registered by the FDA (Federal Drug Administration) on year 2008 and also ISO 9001 certified, the same year that the company landed in Cork, Ireland. In addition, the company acquired the operations of Integratek, an IT/software development company that currently serves biopharmaceutical clients, the banking industry and government. It was on 2011 when Pharma-Bio Serv, Ltd. started to operate in Alcobendas, Madrid under the leadership of Vctor Snchez (a Spaniard born in Zaragoza, and living in Puerto Rico during 10 years) to serve the Spanish life sciences industry; and since then, the company has grown up to employ currently 10 professionals in the three major hubs for the Pharma industry Madrid, Catalonia, and Navarra. The Pharma-Bio Serv competitive advantage is based on the knowledge of the different regulatory markets and specialization on the US FDA regulations. In an environment where Spanish Life Science companies want to expand their businesses to the US, Pharma-Bio Serv offers trained professionals with real handson experience on the US arena. This year 2012, the global operations of Pharma-Bio Serv have experienced a tremendous growth, as a confirmation of its right approach to businesses, coming from a revenue base in fiscal year 2011 of approximately $20 million, to an improvement of approximately 54% for the nine months ended in July 21, 2012 when compared to same period last year. Today, with more than 20 years of experience, the company strives to be positioned in Spain as a Holistic Service Provider and as the leader for cGMP compliance services, retaining, training, and contracting new resources to provide our clients with world class quality. PHARMA-BIO SERV Life Sciences Consultancy Vctor Snchez Altura, President of Europe Operations www.pharmabioserv.com

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Business Case: Pharma-Bio Serv

Interview 1.- Which is the activity of your company in Madrid? We provide a wide range of solutions for the pharmaceutical, biotech, and food industries; since providing cGMP training and validation services to successfully implementing Quality Risk Management Strategies. Completing complex projects as FDA readiness on time and on budget. We are specialized in providing assistance to companies in need to market their regulated products in the USA. 2.- When investing in Madrid, which were the key criteria for the selection of this region? The main reasons for choosing Madrid where: o Madrid is the business centre for Spain. o Madrid has the largest concentration of Life Science industries in Spain, including R&D, Regulatory, Marketing, and Manufacturing business areas. o Madrid is centrally located and a direct connect from US, thus, best communicated region, from the perspective of a company looking for business not only within Spain, but within Europe. 3.- In your opinion, which are the competitive advantages of the Region of Madrid? o Is the geographical centre of Spain and most of the decisions regarding the Spanish market are taken in Madrid. Companies in the life science area will have to come to Madrid to register their products. o It has all kinds of infrastructure; Madrid-Barajas is amongst the best airports in the world, supporting the majority of the national and international routes, and AVEs from Atocha depart to the rest of important business cities in Spain. o Among its population you can find many very well trained, open-minded, young professionals. It is remarkable also how many of those professionals have a good level of English. o Madrids quality of life is known all over the World. Quote: Everyone from all our offices likes to come to Madrid!

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