Development and Lifecycle Management of Software as a Medical Device
The merger provides PharmaLex with a new specialized service line, further strengthening their service portfolio
Friedrichsdorf / Saint-Georges, January 17th 2017: As at 21st December, 2016, the PharmaLex Group, a leading specialist provider of Development Consulting & Scientific Affairs, Regulatory Affairs and Pharmacovigilance, has completed the formal merger with Arlenda.
Arlenda, a Belgium based company, specializes in strategic consulting for clinical and non-clinical statistics. In clinical statistics, Arlenda is focused on the optimization of clinical trial designs by simulation with a specialization in adaptive designs. The company has a particular strength in the field of non-clinical statistics, covering research, CMC and manufacturing. Along the value chain, it is dedicated to method development, validation, transfer and stability testing, analytical methods, bioassays, (bio)processes and stability studies. Besides the consulting activities, Arlenda commercializes software for method validation, method transfer and product stability. Formed in 2003 around its software business, the company has become one of the fastest-growing technology companies in Belgium, adding a consulting division in 2010 and an office in the US in 2011.
“Our key focus is to solve statistical problems in our various fields of competences” explained Benoît Verjans, CEO, Arlenda. “Recent trends show the importance of statistics in the development of robust regulatory files, therefore our statistics services offer great synergies with PharmaLex”, added Bruno Boulanger, Founder and CSO, Arlenda. “We are delighted to welcome Arlenda to the PharmaLex Group. With increasing pressure on clients to provide quality data, we believe this addition will enable us to further strengthen our service portfolio and provide a service specifically focused on compliance” explained Dr. Thomas Dobmeyer, CEO PharmaLex. “Our priority is to provide a high quality services to our clients. With the addition of Arlenda, we have added a specialist service which supports our wider goal of providing confidence beyond compliance” added Dr. Tilo Netzer, CEO PharmaLex.
The PharmaLex Group now has over 500 employees, with 22 offices in 12 countries and more than 550 satisfied clients worldwide.
About PharmaLex <Confidence beyond compliance>:
PharmaLex combines local expertise with global reach in the area of scientific services, regulatory affairs and pharmacovigilance. A proven track record of success in outsourcing programs with more than 25,000 successfully completed projects for over 550 clients worldwide, as well as extensive experience in all therapeutic areas and product groups, including advanced therapy medicinal products and biopharmaceuticals, medicinal and borderline products and alternative therapeutic approaches.
For further information, please contact:
Ms. Eva Keck
PharmaLex GmbH; Director Business Development Operations
eva.keck@pharmalex.com
+49 621 18 15 38 0
Harrlachweg 6; 68163 Mannheim
Germany
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