From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
From Starting Materials through Finished Product Testing, Eurofins BioPharma Product Testing’s 28 facilities in 16 countries deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
As we have grown to become the world’s largest network of GMP product testing labs with a global capacity of more than 115,000 square meters, we continue to uphold our founding promise of personal service and impeccable quality. With facilities located in Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, India, Netherlands, New Zealand, Spain, Sweden, Switzerland, UK and the US, our network of laboratories and vast experience allow us to support projects of any size from conception to market.
We offer the flexibility to manage your testing programs more efficiently through your choice of three unique service models, including our award-winning Professional Scientific Services® (PSS), Full Time Equivalent (FTE) or traditional fee-for-service. You can choose the best, most cost-effective service solution for your project goals.
When the world awaits your product, choose the lab that provides complete capabilities and rigorous quality systems you can trust.
Company name: Eurofins BioPharma Product Testing
Website: www.Eurofins.com/BioPharma
E-mail: pharma@eurofins.com
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.