What you need to know to submit Study Data to FDA
The merger with A.R.C. Pharma will provide clients with access to the extensive range of specialist services offered by the PharmaLex Group
Friedrichsdorf/Mannheim, Germany / Paris, France – October 30th 2018: PharmaLex Group, one of the most experienced and most successful specialist providers of Development Consulting, Regulatory Affairs, Pharmacovigilance, Epidemiology & Risk Management, and Quality Management & Compliance worldwide, has merged with A.R.C. Pharma, a trusted European leader in regulatory affairs and pharmaceutical consulting.
For more than 35 years, A.R.C. Pharma has been servicing the pharmaceutical, biotech & healthcare industry in France. Its highly skilled consultants support over 250 clients every year, advising in areas such as regulatory consulting and audit, management of dossiers, regulatory intelligence, and providing seminars and training courses.
The merger will consolidate two existing industry leading teams in France and will be led by Sophie Guillaume. In addition to providing regulatory consulting and dossier management, the key foundations of A.R.C. Pharma’s business are certified training courses, professional seminars and regulatory intelligence – a personalized regulatory watch, customized to customers’ specific needs. The international structure of the PharmaLex Group and associated brand complement A.R.C. Pharma’s capabilities and extends the portfolio to bring key advantages to clients.
“We are delighted to welcome A.R.C. to the PharmaLex Group”, explained Sophie Guillaume, General Manager, PharmaLex France. “A.R.C. Pharma’s capabilities in regulatory consulting, regulatory intelligence, pricing and reimbursement, as well as training give us an added dimension which is a key advantage in our industry”, she added. “This is an exciting step for us. We are committed to continue delivering the highest quality tailored services, at competitive rates and within timelines. We are proud to achieve this goal thanks to the close relationship we implemented with our clients for many years. Our team of experts remain and will continue to efficiently advise our clients”, explained Sylvie Dulière, Senior Directory, Regulatory Affairs, A.R.C. Pharma. “Through the merger with PharmaLex, we can now offer our clients an even wider range of services whilst retaining our unique style and valued approach”, she added. Dr. Thomas Dobmeyer, CEO, PharmaLex, added “This is an important development for our French office and will ensure we continue to deliver services of the highest quality. Our growing client base can now benefit from A.R.C.’s strategic network of specialists and experts who have regular interactions with national agencies in Europe, EMA and the FDA”.
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About PharmaLex <Confidence beyond compliance>:
PharmaLex is one of the largest providers for Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical development, through regulatory submission processes and finally guide you to market approval and product maintenance post-launch activities. We strive to deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions. We aim to exceed your expectations and live by our values – flexibility, efficiency, passion & dedication.
The PharmaLex Group now has over 750 employees, with 31 offices in 17 countries and more than 600 satisfied clients worldwide.
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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