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The largest network of harmonized bio/ pharmaceutical GMP product testing labs worldwide, Eurofins BioPharma Product Testing enables companies to advance candidates from development through commercialization while ensuring regulatory compliance, cost effectiveness, and achievement of timelines.

pharmaceutical GMP product testing labs … › european-east › media › 3201 › ...BioPharma Product Testing 9515 0414 Created Date 6/19/2014 11:45:34 AM

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Page 1: pharmaceutical GMP product testing labs … › european-east › media › 3201 › ...BioPharma Product Testing 9515 0414 Created Date 6/19/2014 11:45:34 AM

The largest network of harmonized bio/pharmaceutical GMP product testing labs worldwide, Eurofins BioPharma Product Testing enables companies to advance candidates from development through commercialization while ensuring regulatory compliance, cost effectiveness, and achievement of timelines.

Page 2: pharmaceutical GMP product testing labs … › european-east › media › 3201 › ...BioPharma Product Testing 9515 0414 Created Date 6/19/2014 11:45:34 AM

Choose from a wide range of testing services that support all functional areas of bio/pharmaceutical drug development and manufacturing, including method development, microbiology, process validation and quality control.

Our service offerings are fully comprehensive and include testing of drug substance, final product, intermediates and starting materials for both small and large molecule drug products, 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 • Testing of packaging components

The most comprehensive range of large and small molecule testing services available, worldwide.

Page 3: pharmaceutical GMP product testing labs … › european-east › media › 3201 › ...BioPharma Product Testing 9515 0414 Created Date 6/19/2014 11:45:34 AM

Global facilitiesWork with any of our state-of-the-art facilities to receive the highest level of instrument technology and capacity to support projects of any size and scope. Our global capacity of more than 50,000 square meters among our 14 facilities includes:

In addition to these laboratory locations, we have teams of scientists placed at more than 35 client facilities throughout the U.S. and Europe through our Professional Scientific StaffingSM insourcing program.

Gent, BelgiumCopenhagen, DenmarkColmar, FranceLyon, FranceParis, FranceMunich, GermanyHamburg, Germany

Dungarven, IrelandMilan, Italy Siena, ItalyBarcelona, SpainUppsala, SwedenMichigan, U.S.Pennsylvania, U.S.

Page 4: pharmaceutical GMP product testing labs … › european-east › media › 3201 › ...BioPharma Product Testing 9515 0414 Created Date 6/19/2014 11:45:34 AM

Receive the same level of service at any of our facilities. From technology and expertise to laboratory procedures and standards, our laboratories offer you a single resource to meet all of your GMP testing needs with the same LIMS, strict quality procedures, centralized billing system and online data access.

Today, nearly 2,000 employees of Eurofins BioPharma Product Testing operate under the same Global Quality Policy Manual and utilize the same CAPA/Exceptions Management System and Document Management System.

Manage your projects more efficiently through your choice of four unique service models. From the traditional Fee-for-Service model, to our Managed Hours, Full Time Equivalent and award-winning Professional Scientific StaffingSM programs, you can choose the best, most cost-effective service solution for your project goals at any of our global facilities.

Harmonized systems, strategic service models

Page 5: pharmaceutical GMP product testing labs … › european-east › media › 3201 › ...BioPharma Product Testing 9515 0414 Created Date 6/19/2014 11:45:34 AM

Get timely and secure access to comprehensive laboratory information through our innovative, online data access tool, LabAccessSM.com. View extensive, live project information such as submitted samples, analysts’ notebooks, chromatograms, approved test results, Certificates of Analysis, raw data packages and invoices for any project within any of our laboratories.

Our system is capable of providing:

• 24/7 data access on virtually any desktop, laptop or mobile device.

• The ability to Export Results to measure product performance over time.

• A stability calendar to view your stability studies in progress.

• Certificates of analysis that contain our laboratory’s QA release electronic signature.

Convenient online data access

Page 6: pharmaceutical GMP product testing labs … › european-east › media › 3201 › ...BioPharma Product Testing 9515 0414 Created Date 6/19/2014 11:45:34 AM

Most trusted laboratory

Work with the lab that more than 5,000 global pharmaceutical and biopharmaceutical companies trust for their testing needs. With a stable, highly trained workforce and local, dedicated Project Managers, we have the highest customer satisfaction in the industry. Some of our laboratories’ achievements include:

• Winner of the 2013 and 2014 CRO Leadership Award, ranking in the top 20 percentile in quality, reliability, productivity and innovation.

• Client satisfaction rates as high as 95% per feedback on annual client surveys

• Award-winning Professional Scientific StaffingSM program with six strategic supplier awards.

Page 7: pharmaceutical GMP product testing labs … › european-east › media › 3201 › ...BioPharma Product Testing 9515 0414 Created Date 6/19/2014 11:45:34 AM

www.eurofins.com/Biopharma

BioPharmaProduct Testing

9515 0414