Delivering a true local lab experience with the largest global network of harmonized GMP BioPharma Product Testing sites
Timothy S. Oostdyk, Ph.D., President, Eurofins Lancaster Laboratories, Sr. Vice President, Eurofins BioPharma Product Testing Group
As the largest global network of harmonized BioPharma GMP product testing laboratories, our fundamental philosophy is to enable clients to effectively allocate their research and manufacturing expenditures by strategically engaging them to meet their unique outsourcing needs.
Listening to our clients’ exciting new product development goals, global regulatory approval requirements and budgetary and timeline challenges, inspires and ignites a drive to be there for them--literally--wherever they are in the world.
Developing and releasing products in many different markets, our clients require the same consistent level of expertise, quality, best practices, and service options to be delivered across our network.
And that is why, as our business has grown around the world, to effectively serve clients’ needs, our BioPharma Product Testing Group offers harmonization among our 14 GMP facilities, located in nine countries. The same quality system. The same LabAccess customer interface. The same individualized customer service. All right in our clients’ backyard.
The result of our harmonization initiatives is that all of our laboratories operate under the same Global Quality Policy Manual and utilize the same CAPA/Exceptions Management System and Document Management System. This ensures efficiency for our customer’s audits, and consistency in the approach, content and quality of laboratory investigations.
Further, with our global online portal, LabAccess.com, clients working with any of our laboratories are able to review project data and reports 24/7. Project information such as reports, test results, and status of samples for any project within the Eurofins BioPharma Product Testing network are available through this secure online portal.
By working with one harmonized international biopharma GMP product testing provider, Eurofins’ clients can appreciate various enhanced capabilities and benefits. Among all of our labs, we require collaboration on services, regulations and new technology and ensure that our laboratories operate with a concordant level of scientific expertise. This drives consistency and excellence for clients marketing products in various regulatory environments. (See article on US and EU product release testing for examples of collaborative initiatives for clients grappling with multiple regulatory authority approvals.)
Our harmonized network supports all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control. Further, our network provides testing for nearly all stages of the drug development process, ranging from pre-clinical through post-product approval, including: testing of all starting materials, process and product related impurities, method development and validation, stability and release testing, process/facility validation, virus clearance and safety, and testing of packaging components.
Beyond the breadth of our service offerings, as many of our clients know and appreciate, our value is really enhanced by our service models. Specifically, in addition to our Fee-For-Service capabilities, we have also harmonized all service models to include our Managed Hours program, Full Time Equivalent program, and our award-winning Professional Scientific StaffingSM program, which has grown to include more than 35 locations in seven countries.
We believe strongly that this harmonization and collaboration among our global Eurofins BioPharma Product Testing sites greatly enhances our ability to serve our customers. While providing a true local lab experience, our international presence ensures the most complete range of global testing services, where you need them.
We make it our business to effectively balance delivering the most complete range of GMP harmonized testing services on a global platform, while meticulously treating each client as if they were our only one.
On behalf of our nearly 2,000 employees, thank you for your business and for the trust you have placed in us. We look forward to continuing to serve you.