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SCHOTT Pharma Offers Complete Testing Suite for Container Selection and Drug Submission Preparation - Registered with the Food and Drug Administration (FDA) as an independent lab, SCHOTT Pharma has completed its testing suite to help pharmaceutical companies accelerate drug submission - SCHOTT-Pharma.com
SCHOTT Pharma Offers Complete Testing Suite for Container Selection and Drug Submission Preparation

 

NewswireTODAY - /newswire/ - Mainz, Rhineland-Palatinate, Germany, 2024/03/04 - Registered with the Food and Drug Administration (FDA) as an independent lab, SCHOTT Pharma has completed its testing suite to help pharmaceutical companies accelerate drug submission - SCHOTT-Pharma.com.

   
 
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• SCHOTT Pharma’s PartnerLab is a one-stop shop for drug developers, covering full range of analytical tests needed for drug submission;
• As a trusted partner to the pharma industry, SCHOTT Pharma’s analytical services help drug developers streamline complexity, ensure quality of products and bring them to market faster.

“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 coordinate 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. 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.

“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.”

Learn more about SCHOTT Pharma’s range of lab services and analytics that help to safely bring drugs to market.

About SCHOTT Pharma

Human health matters. That is why SCHOTT Pharma (schott-pharma.com) designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023.

 
 
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Agency / Source: SCHOTT North America

 
 

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SCHOTT Pharma Offers Complete Testing Suite for Container Selection and Drug Submission Preparation

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PartnerLab | SCHOTT Pharma
Contact: Joana Kornblum - SCHOTT.com 
joana.kornblum[.]schott.com
 
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