Sharp, part of UDG Healthcare plc, a global leader in contract packaging and clinical supply services, has appointed Ria Rhemrev-Boom as its new lead EU Qualified Person (QP) for market release services.
In her new role, Ria will take responsibility for leading Sharp’s QP release to market services for its customers, ensuring the medicines manufactured, packaged and handled throughout the supply chain comply with EU GMP rules and all applicable regulatory standards.
Ria has a PhD in Medical Science from the University of Groningen and has worked across a number of key roles in the pharma and biotechnology industry in a career spanning over 35 years, including R&D manager, Lab Director and CEO for a variety of service organisations. She has extensive experience in delivering QP services and implementing quality management systems (QMS).
Robert O’Beirn, Managing Director of Sharp Europe, said: “Ria’s appointment is a key part of Sharp’s strategy of ensuring we offer a full suite of services for our customers. This will be particularly important to biotech manufacturers and virtual businesses as they often require support in the EU in relation to the release of their products onto the market.
“She will be instrumental in helping to streamline the journey of our customers’ products to market in the EU and will further enhance the strong quality culture in the Sharp EU organisation, led by Chris Bruyninckx, QA/RA Manager of Sharp Europe.
“We continue to focus on quality and improving the services we offer to our clients. With our global network of facilities, the addition of Ria leading our QP release to market service will ensure we offer an enhanced customer experience as we help clients meet the unique regulatory demands in the EU.”
Complemented by Sharp’s new cloud-based QMS, QualityOne, and the implementation of an Electronic Batch Record infrastructure, the addition of QP market release services means the company can now offer enhanced packaging and release services. These new capabilties will help pharmaceutical companies around the globe to bring their products to the market faster and more efficiently.
Sharp, part of UDG healthcare, is a global leader in advanced clinical supply chain services and contract pharmaceutical packaging. Offering solutions and support to pharma and biotech clients from phase I trials all the way through to commercialization and rapid launch. The organisation has state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands and over 32 clinical depots globally, covering every region of the world.
Our full complement of integrated services includes: analytical, formulation development, clinical manufacturing & packaging, clinical IRT, blister packaging, bottling, secondary assembly and labelling of injectable presentations, compliance packaging, as well as storage and distribution. Sharp also offers Qualified Person (QP) services for European distribution.
Through our partnership with Berkshire Sterile Manufacturing we also offer specialist isolator-based filling of vials, syringes, cartridges and containers, as well as lyophilization and terminal sterilization.