Registered with the Food and Drug Administration (FDA) in the U.S. as an independent lab, SCHOTT Pharma has completed its testing suite to help pharmaceutical companies accelerate drug submission.
“The testing and submission processes for new drugs are complex, time- and cost-intensive,” said Andreas Reisse CEO of SCHOTT Pharma. “With our deep understanding of regulatory requirements and processes, we are supporting drug developers with a one-stop solution to simplify and accelerate the entire drug development journey.”
SCHOTT Pharma’s analytic testing capabilities reinforce the company’s scientific expertise, which stems from decades of developing solutions for the pharmaceutical industry. The extensive line of services including drug and material compatibility testing is now completed by functional testing and container closure integrity testing (CCIT). The lab is accredited according to DIN EN ISO/IEC 17025.
A typical drug development journey spans multiple years with the clinical phase being essential in testing, developing and processing a product before submitting it to the authorities for approval. In this stage, drug manufacturers need access to specific technology, personnel resources and expertise to complete numerous tests, while navigating the complex regulatory landscape from the FDA.
Now, with SCHOTT Pharma’s PartnerLab, drug developers benefit from a one-stop solution fulfilling all testing demands ranging from functional testing, and CCIT, to delamination studies, and particle analysis, among other capabilities. In order to meet various market requirements, the lab is able to test all materials – from glass to rubber components and polymer. The complete package with robust documentation and guidance thereby helps to relieve complexity, accelerate submissions and offer assurance that the testing process was completed accurately and reliably.