The importance of GxP Compliance for Global Cannabis Production
The merger with TRAC Services will further consolidate our industry-leading team in the UK, strengthening our core services and bringing regional expansion in regulatory affairs
Frankfurt, Germany / London, UK, 21st November 2017: As at 10th November, 2017, the PharmaLex Group, a leading specialist provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance Services as well as Pharmacovigilance, has completed the formal merger with TRAC Services Limited (TRAC).
TRAC was founded in 2001 by Jonathan and Sarah Trethowan and has an outstanding reputation in regulatory services, particularly CMC regulatory affairs, MAA compilation and submission, post approval and licence maintenance, procedural management, eCTD publishing and package leaflet readability testing. They have built up an impressive client list, including several of the top 10 global pharma companies.
PharmaLex has a highly regarded, industry-leading team of Development Consulting, Regulatory Affairs and Pharmacovigilance consultants which is led by Jon Jeffery, Managing Director, and is located in one of the UK’s pharmaceutical heartlands, near London Heathrow. Jon will lead the extended country organisation; in Regulatory Affairs, this exciting merger strengthens our core services and results in an even more accomplished organisation in the UK, which now also benefits from having the office and team in TRAC’s complementary location of Cornwall in the South West.
Alongside Jonathan Trethowan’s role at TRAC, he also works closely with the pharma industry in the UK. He was President of TOPRA (The Organisation for Professionals in Regulatory Affairs) in 2014 and is a member of EMIG’s (Ethical Medicines Industry Group) Regulatory Steering Group which sees him in regular contact with the UK regulator, the MHRA as well as ABPI (Association of the British Pharmaceutical Industry).
“The UK is an important market for us as well as stepping stone to Europe for customers from other regions, particularly North America, and developing our UK business is a key strategic goal”, explained Dr. Thomas Dobmeyer, CEO PharmaLex. “We welcome Jonathan and his team to the PharmaLex Group. Their experience and commercial model will make an important contribution to our existing UK business, further expanding how PharmaLex can support our customers, not only in the UK, but internationally too”, Dr. Tilo Netzer, CEO PharmaLex added.
“With a shared culture and the same commitment to quality we are confident our clients will benefit from TRAC joining the PharmaLex Group, explained Jonathan Trethowan, Managing Director, TRAC Services Limited. “These benefits include, but are not limited to, improved geographical reach, increased capacity and access to additional services”, he added.
The PharmaLex Group now has over 650 employees, with 26 offices in 14 countries and more than 600 satisfied clients worldwide.
-Ends-
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
eva.keck@pharmalex.com
+49 621 18 15 38 158
Harrlachweg 6; 68163 Mannheim,
Germany
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