Registered with the US Food and Drug Administration (FDA) 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 extensive 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.
In many cases, drug developers outsource the process to different external suppliers to complete each test and have to co-ordinate several entities while under time pressure.
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.
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.
“With our scientific expertise, we want to help start-ups and small pharmaceutical companies, for example, who often develop products with great potential but struggle to overcome the hurdle of the complex submission process,” says Dr Arne Kloke, Head of Services and Sustainability at SCHOTT Pharma.
“Besides that, all pharmaceutical companies, including Big Pharma, benefit from our complete testing suite combined with the expertise to identify and solve root cause challenges.”
