The merger with McGee Pharma International brings additional resource and significant experience in quality management and compliance services
Friedrichsdorf, GERMANY / Dublin, Ireland, August 28th, 2017: As of 17th August, 2017, the PharmaLex Group, a leading specialist provider of development consulting, regulatory affairs, quality management & compliance, as well as pharmacovigilance, has completed the formal merger with McGee Pharma International (MPI).
MPI was founded in 2004 by Ann McGee and is based in Dublin, Ireland. They combine cutting edge EU and FDA quality and technical insight with best-in-class product manufacture (GMP), distribution (GDP) and post market (MAH) quality, compliance and technical support services. These services are tailored to meet the needs of all of MPI’s 200+ clients.
This merger will help to strengthen our existing quality and compliance expertise provided by Complya, a division PharmaLex merged with earlier this year in the US. The addition of one of the leading Irish consultancies will enable PharmaLex to provide both US and EU clients with industry leading quality management and compliance solutions. This merger will help to accelerate and innovate compliant patient care. The focus on GMP, GDP and MAH compliance coupled with the strength of the Pharmalex Group in Regulatory Affairs, GCP and Pharmacovigilance, will enable the Group to integrate their approach across their operations to provide a seamless solution to client’s compliance requirements both in the US and EU. The transaction also allows PharmaLex to better serve its clients in Ireland – a country with an important global economic pharma footprint.
“The merger allows us to build on our existing quality and compliance expertise and to further expand our geographic reach”, explained Dr. Thomas Dobmeyer, CEO PharmaLex. “We are glad to have Ann, with her team of 50 technical experts on board, to service our client needs for EU and US GxP quality, compliance, manufacturing and product development”, Dr. Tilo Netzer, CEO PharmaLex added. “We are very excited to be joining the PharmaLex Group. Being part of an international service provider enables us to provide existing clients with a wider range of services as well as support clients in new markets and locations”, said Ann McGee, Managing Director, McGee Pharma International.
The PharmaLex Group now has over 650 employees, with 25 offices in 14 countries and more than 600 satisfied clients worldwide.
About PharmaLex <Confidence beyond compliance>:
Development Consulting, Regulatory Affairs, Quality Management & Compliance as well as Pharmacovigilance – are our core service areas. Whether you are looking for maintenance activities covering entire portfolios or are interested in bench-to-market guidance during product development and beyond, our worldwide teams are available when and where you need them. Our working models can be tailored to fit client needs to consistently deliver milestone achievements and exceed expectations. Our extensive experience covers all major therapeutic areas and most product categories beyond the traditional medicinal products, including advanced therapy medicinal products, orphan drugs, biosimilars and medical devices.
For further information, please contact:
Ms. Eva Keck
+49 621 18 15 38 158
Harrlachweg 6; 68163 Mannheim,