The pharmaceutical and medical device regulatory hurdles companies can encounter in Europe are significant but not insurmountable. Our involvement ensures the routes to market remain open and are unencumbered by unnecessary delays.
Horsham, West Sussex (PRWEB UK) 22 May 2012
Regulatory affairs consultants and regulatory submissions experts Spectrum Regulatory Solutions, showcase a suite of market access and regulatory services with their new website launch.
“Over the last 2 years our services have increased in depth and breadth to include market access and full lifecycle management in the pharmaceutical and medical device sectors.” says Trevor Brett, Commercial Director. “Our clients are now not only using us for outsourcing their regulatory submissions, safety and device vigilance needs, but increasingly for regulatory affairs strategy and market access consultancy.”
Working across the whole spectrum of European countries, Spectrum is an obvious first point of call for North American pharmaceutical companies and medical device manufacturers to plan EU market access routes as well as post-marketing surveillance activities in Europe.
“The pharmaceutical and medical device regulatory hurdles companies can encounter in Europe are significant but not insurmountable. Our involvement ensures the routes to market remain open and are unencumbered by unnecessary delays.”
Across Europe, the company has networks of talented professionals with significant industry experience in a wide variety of therapeutic areas. Such services also include translation in all EU languages as well as patient information leaflet testing.
In the UK, Spectrum RS has increasingly undertaken consultancy work on Health Economics and Outcomes Research and Health Technology Assessments. “This work is key to ensuring medical devices and pharmaceutical products prove their value for money for national healthcare systems.” Over 40 HTA submissions have recently been made to NICE, SMC and AWMSG over a wide range of therapeutic areas for pharmaceutical products and medical devices.
“With the launch of our new website, it’s clearer than ever before that we offer a wide range of services, strategy and consultancy in the regulatory affairs sector as well our core medical writing services. It’s making clear our commitment to our major pharmaceutical clients and medical device manufacturers with a suite of products that provide a full service regulatory consultancy model.”
About Spectrum Regulatory Solutions
Spectrum Regulatory Solutions have built their reputation for quality, reliable and responsive EU regulatory affairs consultancy services with major healthcare companies worldwide since 2005. Spectrum Regulatory Solutions is part of the Zaicom International group of companies. The results speak for themselves: at least 70% of our business comes from repeat client work and referrals. Our rigorous approach builds quality into every project and assures compliance.
Press Contact: Ellie Coutts
Please call +44 (0)1403 320 280 for more information or interviews.
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