Regulations & EHS&S

PharmaLex shortlisted in the prestigious CPhI Pharma Awards 2019

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 recognise 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 benefited the development of various CMC areas such as definition of critical quality attributes, process characterisation, 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 recognised 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.