American Medical Device Summit
The merger demonstrates PharmaLex’s commitment to the US market and complements its existing EU medical device expertise
Friedrichsdorf / Indianapolis, IN, April 21st 2017: As of 7th April, 2017, the PharmaLex Group, a leading specialist provider of development consulting and scientific affairs, regulatory affairs and pharmacovigilance, has completed the formal merger of Safis Solutions.
Safis Solutions is headquartered in Indianapolis, IN, USA. Founded in 2002, the company specializes in regulatory affairs, having a particular strength in medical devices. Working with companies in the regulated life science industry, Safis Solutions provides expertise in medical products regulatory registration and market clearance consulting, as well as regulatory compliance, quality systems, validation and auditing services.
“The acquisition enables PharmaLex to complement its existing EU medical device expertise with high quality and established US medical device capabilities”, explained Dr. Thomas Dobmeyer, CEO PharmaLex. “It will help establish us as a key provider in the US”, he continued. Dr. Tilo Netzer, CEO PharmaLex, added, “The provision of this additional regulatory experience will help support making us a partner of choice for global medical device and combination product projects. It is further evidence of the importance we are placing on our US business”. “We are delighted to be joining the PharmaLex Group” said Ping Poulsen, Founder, Safis Solutions. “Not only can we expand our breadth and depth of expertise by being part of a global multi-national company, but a more mature infrastructure will allow us to offer our clients a more comprehensive service portfolio”, she added.
The PharmaLex Group now has over 550 employees, with 23 offices in 12 countries and more than 600 satisfied clients worldwide.
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About PharmaLex <Confidence beyond compliance>:
PharmaLex combines local expertise with global reach in the area of development consulting and scientific services, regulatory affairs and pharmacovigilance. A proven track record of success in outsourcing programs, more than 25,000 successfully completed projects for over 600 clients worldwide, as well as extensive experience in all therapeutic areas and product groups, including advanced therapy medicinal products and biopharmaceuticals, medical and borderline products and alternative therapeutic approaches.
For further information, please contact:
Ms. Eva Keck
Director Business Development Operations, PharmaLex GmbH
eva.keck@pharmalex.com
+49 621 18 15 38 0
Harrlachweg 6; 68163 Mannheim,
Germany
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