Cambridge, UK, June 6 2012 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today announces that it has formed a preferred European partner relationship with mdi Europa GmbH, a global regulatory consultancy for medical device and IVD companies. The two companies are partnering to provide a complete, end-to-end regulatory solution for medical device manufacturers in Europe – spanning initial device registration and documentation to CE marking and post-marketing services.
ELC Group has developed a strong track record and extensive expertise in medical device regulatory services, including regulation strategy, Medical Device Directive consultancy, device registration, and full technical file preparation. Through its Preferred Partnership arrangement with mdi Europa, ELC Group is now able to offer a one-stop, full-service consultancy solution to medical device manufacturers, focused on speeding time-to-market and easing the compliance process. With this new total service solution, ELC Group’s strengths in documentation support are complemented by mdi Europa’s skills in guiding companies to achieving CE certification and approvals, plus post-marketing device vigilance.
Commenting on today’s announcement, Marco Rubinstein, CEO of ELC Group said: “By joining hands with a regulatory organisation of the calibre of mdi Europa, we are offering our customers a true best-in-class solution for end-to-end medical device compliance. The breadth of this combined solution means that customers can benefit from a smoother regulatory process and faster time-to-market, all in the confidence that they are getting the very highest quality consultancy, support and advice available.”
mdi Europa Vice President Operations, Martina Sander-Giesemann, added: “It was most important for us to find a partner that has an equal understanding of customer service. With ELC Group, we have found an experienced, well-positioned partner that focuses on customer needs in the same way as we do. Regulatory compliance is often felt to be a burden – together with ELC Group, we do our utmost to take this burden off our mutual clients.”
ELC Group helps clients expedite time-to-market through a broad range of development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialisation services. ELC Group delivers its customised solutions through four core business segments: Regulatory Affairs Services; Medical Devices; EU REACH (Registration, Evaluation and Authorisation of Chemicals) Regulation Services; and Corporate Languages Solutions (Translations, Design, DTP, Localisation).
ajain [at] elc-group [dot] com
Phone: +420 22 491 00 00
nicky[at] evokedset [dot] com
Phone: +44 (0)7747 017654
About ELC Group
ELC GROUP is a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries as well as REACH services to the Chemical industry. It helps companies that lack the resource (skills and knowledge) to cost effectively deliver regulatory affairs.
ELC Group provides full-service, multi-lingual consulting and cost-effective solutions to regulatory approvals using experts with in-depth knowledge and experience throughout the world. The team ranges from former FDA investigators to individuals with over 30 years of industry experience with broad capabilities. This includes integrated advanced technologies, regulatory affairs consulting and commercialisation services.
About mdi Europa GmbH
mdi Europa is a regulatory affairs consulting company specializing in CE-marking and regulatory affairs for both the medical and in vitro diagnostic medical device manufacturing industry. Its predominant role is that of “authorized representative”; a prerequisite for all non-European manufacturers without a subsidiary / place of business within the European Union. Services include labeling review, product registration, post market surveillance, product classification, vigilance, language requirements and general guidance in interpreting the Directives 90/385/EEC, 93/42/EEC & 98/79/EEC. For more information, visit www.mdi-europa.com