Serialisation – New EU Aide Memoire for GDP
The merger reinforces PharmaLex’s intentions to build its US business following its recent acquisition of Safis Solutions
Friedrichsdorf, GERMANY / Washington, USA, May 2nd, 2017: As of 24th April, 2017, the PharmaLex Group, a leading specialist provider of development consulting and scientific affairs, regulatory affairs and pharmacovigilance, has completed the formal merger with The Degge Group, Ltd. The company is based just outside Washington, DC, in Fairfax, Virginia, USA.
The Degge Group’s focus on pharmacoepidemiology and pharmacovigilance services as well as regulatory consulting, including Rx/OTC switches, both within the US and worldwide further strengthens the PharmaLex portfolio of services. Its clients include major pharmaceutical companies alongside large and small biopharmaceutical companies, medical device manufacturers, nutritional food companies, consulting companies, and non-profit organizations.
The Degge Group was founded in 1988 by Judith K. Jones, MD, PhD, FISPE. Judith was a member of an FDA OTC Advisory Panel and went on to serve as FDA’s Director of the Office of Safety and Epidemiology. She also formerly served as President of The International Society for Pharmacoepidemiology (ISPE) and The Drug Information Association (DIA), and currently sits on the Standardized Medical Queries (SMQ) panel at the Council for International Organizations of Medical Sciences (CIOMS), and the United States Adopted Names (USAN) Council.
“The addition of The Degge Group further establishes our intentions to build our US presence following our recent acquisition of Safis Solutions,” explained Dr. Tilo Netzer, CEO PharmaLex. Dr. Thomas Dobmeyer, CEO PharmaLex, added, “In the present era of large-scale global investigations and safety issues, The Degge Group enhances the PharmaLex Group’s offerings with its pharmacoepidemiology expertise and its specialized staff.” “We are delighted to be joining the PharmaLex Group” said Dr. Judith Jones, President and CEO, The Degge Group. “Drawing upon three decades of experience in scientific and regulatory aspects of medical product epidemiology, regulatory expertise, and safety studies, our strategic services build up PharmaLex’s ability to address the needs of today’s biopharma and medical product industry,” she added.
The PharmaLex Group now has over 570 employees, with 24 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. PharmaLex has 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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