The importance of Quality System Audits
They have been recognized for their approach to CMC development
Frankfurt, Germany – 23rd October 2019: 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 been shortlisted for the CPhI Pharma Awards 2019.
CPhI is an established pharmaceutical event hosting numerous conventions, seminars and awards across the world. Now in their 16th year, the CPhI Pharma Awards recognize the innovation and dedication of companies and individuals who are driving the pharmaceutical industry forward.
PharmaLex entered the awards under the ‘Excellence in Pharma: Regulatory Procedures and Compliance’ category. Under the title: Lean but Mean – Approaches to CMC Development, PharmaLex explained how their streamlined approach helped clients to avoid complex risk-based assessments by using a simplified scoring system. They provided evidence of how this approach has benefitted the development of various CMC areas such as definition of critical quality attributes, process characterization, comparability studies and innovative approaches to stability and process validation. As well as highlighting the significant savings in time, resource and costs that having open collaboration with the regulators brings.
The judges will be looking for evidence of Innovation in technologies, products, processes, and services designed to aid and ensure that bio/pharma companies comply with guidance documents established by regulatory authorities.
“Being shortlisted by CPhI is very exciting”, explains Dr. Jörg Strähle, Senior Director, CMC Services at PharmaLex. “It demonstrates the innovative approach we take to ensure we deliver the best possible outcome for our customers”, he added. “CPhI have recognized PharmaLex as a leading service provider in a competitive field”, Dr. Thomas Dobmeyer, CEO PharmaLex, commented. “We would obviously love to win but the fact we have been shortlisted alongside other global companies, is a major milestone for our company”, he added.
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About PharmaLex <Confidence beyond compliance>:
PharmaLex is one of the largest providers of specialist services for Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide. Our global teams of experts can take you through early strategic planning activities and non-clinical 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 and dedication.
The PharmaLex Group now has over 900 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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