Quality Risk Management ICH Q9 – Revision published for public comments
The partnership will help accelerate early phase development
BioMotiv (Cleveland, OH) and PharmaLex (Mannheim, Germany / Fairfax, US) – October 16th 2018: PharmaLex Group, one of the largest and most successful specialist providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide, has entered into a preferred partnership with BioMotiv, a mission-driven accelerator that advances breakthrough discoveries from research institutions into therapeutics for patients.
BioMotiv and PharmaLex are currently collaborating on a novel anti-inflammatory product for Koutif Therapeutics. The specialist expertise required to accelerate early phase development is a specific strength of PharmaLex, and the success of this existing relationship has resulted in a new preferred partner agreement between the two companies.
For BioMotiv, the partnership ensures a standardized and consistent approach to all portfolio companies, leveraging ongoing successes, streamlining processes and implementing changes. For PharmaLex it is an opportunity to build on their global strategic pillars. “We can utilize our expansive specialist knowledge across multiple disciplines, to partner with clients to provide tailored services that represent greater value and act as an extension of their team”, explained Adrian Pencak, Global EVP of Business Development. “To be able to do this with BioMotiv – innovators in getting products to market faster – is very exciting”, he added.
“We are very pleased to have finalized the preferred partnership between BioMotiv and PharmaLex”, explained Teresa M. Byrne, Director, Clinical and Regulatory Operations, BioMotiv. “This preferred partnership will not only include PharmaLex ‘back-office’ services for early phase Regulatory Affairs, Pharmacovigilance, and Quality Management across all of BioMotiv’s portfolio companies, but will also include the opportunity for ad-hoc requests that fall outside of these areas”, added Jeff Edelson, Chief Medical Officer, BioMotiv. “Our new partnership with BioMotiv exemplifies the value of our expertise across all specialist areas which will help ensure patients are able to access treatments faster”, explained Andy Verderame, Partner, PharmaLex US Regulatory Affairs and Development Consulting. “It will also provide a single consistent process and tailored approach for BioMotiv across all of their portfolios”, added Dr. Thomas Dobmeyer, CEO, PharmaLex.
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About BioMotiv
BioMotiv is the mission-driven accelerator associated with The Harrington Project for Discovery & Development, a $340 million initiative for advancing medicine centered at University Hospitals in Cleveland. The focus is to accelerate breakthrough discoveries from research institutions into therapeutics for patients through an innovative model that efficiently aligns capital and collaborations. The company leverages an experienced team and advisory board to select, fund, and actively manage and advance a portfolio of drug development programs.
For more information, go to: www.biomotiv.com.
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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