2012-10-25 11:09:31 - Global compliance services and product business brings in Dr Peter Clarke to further develop US offering
25 October 2012 – Global compliance specialist GXPi has chosen Dr Peter Clarke to drive and manage growth for the US operation. The appointment comes only weeks after GXPi showed its intent to give increasing focus to the US market by moving to new offices in New Jersey.
Bringing nearly three decades of experience in the European and US biopharmaceutical industry, Dr Clarke adds significant experience in an increasingly global market where multiple regulators and complex compliance standards need to be understood.
CEO of GXPi Keith Williams commented: “The appointment of Dr Clarke marks an important moment for GXPi as a whole. The alliances we have made with our US partners are developing quickly and are extremely important to us. We have
appointed Peter because of his network, experience and pragmatic perspective, having worked at the heart of the US regulatory environment for over a decade. We are confident he will prove a valuable addition to our management team and bring our product and service offerings to a wider audience in the US.”
GXPi has provided expert consultancy to the global life sciences sector for over 10 years, creating partnerships with Companies including GlaxoSmithKline, Novartis, DSI, and Novozymes. More recently, GXPi has provided its enterprise grade Document and Training management products to the US market. This is driving growth, resulting in the move to new offices in New Jersey, though headquarters are still based in Nottingham, UK.
Dr Clarke commented: “I am looking forward to building on GXPi’s excellent reputation in the life sciences sector. My aim is to extend GXPi’s existing client base in the US and to facilitate the vital mission of our partners in providing sustainable solutions to their patients. I am excited to work with GXPi whose suite of effective products and services support our partners’ drive to assure positive patient outcomes.”
For more information on GXPi’s products and services go to www.gxpi.com.
About Peter Clarke
Dr Clarke supports GXPi through Pharma Compliance Consulting, LLC, where he is principal consultant and owner. He has worked for over 28 years in the biopharmaceutical industry in positions of increasing responsibility in both Europe and the US.
Beginning as a research scientist Dr. Clarke has developed his career in Manufacturing and Technical Operations, with expertise in design, validation and operation of biopharmaceutical manufacturing, their associated analytical methods and clinical/commercial supply chain.
As part of the licensure of a range of diverse biopharmaceutical products, Dr. Clarke has interacted directly with Regulatory Agencies including FDA (CBER and CDER), EMA, BfArM, IMB, MHRA, DHMA and AIFA. This, combined with his direct experience of bringing new products to market, puts him in the best position to deliver GXPi’s high value consultancy services, and, as a well-informed user, advise customers on the best application of its enterprise grade products designed specifically to ensure compliance for the life sciences sector.
GXPi’s New US Office: 33 Wood Avenue South, Suite 600, Iselin, New Jersey, 08830.
GXPi simplify complex process and technology environments to deliver our customers’ compliance and quality goals within their regulatory framework. We achieve this through a combination of products and services designed specifically for compliance requirements in the life sciences sector.
GXPi’s products, X-Docs™ and X-Train™, provide enterprise grade electronic Document, Content and Compliant training solutions.
GXPi’s services cover all aspects of regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GDP), qualified person (QP), quality assurance (QA), and validation particularly with Computerised and Information Technology (IT) systems.
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