INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-1572385009 production, facility, manufacturing, pharma]( "Data-Driven Methods for Ensuring Container Closure Integrity")
Data-Driven Methods for Ensuring Container Closure IntegrityAn integral component to a robust quality control program is container closure integrity testing (CCIT), which helps ensure the prevention of contamination and/or the degradation of a product.
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![GettyImages-186750891-Isolator]( "Industry Insights In Isolator Technologies And Aseptic Processing In Pharma")
Industry Insights In Isolator Technologies And Aseptic Processing In PharmaExplore an overview of trends and insights in isolator technologies and aseptic processing in the pharmaceutical industry.
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![Medical scientists analyzing research-GettyImages-1413600685]( "Developing A Comprehensive Regulatory Approach For LNP Drugs")
Developing A Comprehensive Regulatory Approach For LNP DrugsThe path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.
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![GettyImages-1132960495 EU European Union flag]( "What The Shift To The EMA's PMS Means For Industry")
What The Shift To The EMA's PMS Means For IndustryExplore the implications of the shift to the European Medicines Agency's Pharmacovigilance System Master File (PMS) database for the pharmaceutical industry.
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ICH Q12 Implementation: Regulatory Intelligence And PACM Agility7/9/2024
Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.
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Removing The Headache: Outsourced Stability Storage And Testing Solutions12/4/2024
Should you manage certain operations internally or partner with a trusted external provider? Watch experts discuss the benefits of outsourcing stability, storage, and testing.
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Unlocking The Potential Of Digital Transformation Tools In The Biopharmaceutical Industry10/4/2024
Why do many BioPharma organizations still struggle to gain the crucial benefits they desire from their data and digital transformation tools?
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A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks6/6/2024
A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. The facility had to have the ability to be repurposed for additional applications.
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A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-1214763114 Medical Research Scientist Working In Laboratory]( "Culture Media For Biological Indicators")
Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.
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![GettyImages-1927881398-consulting-office-computer-windows]( "Computerized System Validation Services")
As your personal partner and pharma consulting expert, we sincerely understand the specific process and regulatory challenges of pharmaceutical, biotech, and medical device manufacturers in detail.
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![files iStock-1277601366.jpg]( "Document Control Software For Life Sciences")
Digital document control systems introduce automation into your processes. A digital solution is not only more efficient, it also makes it easier to keep up on regulatory changes and maintain compliance.
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![beckman optima xpn]( "Optima™ XPN Ultracentrifuge")
1,500 mL max rotor capacity 100,000 max RPM 802,400 x g
Security and tracking Remote monitoring and control eXPert simulation software.
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![Vaccines]( "Cleanrooms And Equipment For Vaccine Drug Manufacturing")
Solutions for rapid response to vaccine development and manufacturing challenges
Vaccine development trends emphasize the need for adaptability and accessible production facilities. Remote manufacturing tackles these challenges, facilitating decentralized vaccine production and rapid responses to health crises. Germfree, a leading cleanroom manufacturer, remains at the forefront of these trends by providing configurable solutions that satisfy regulatory requirements and end-user needs. By leveraging innovative remote manufacturing technologies, Germfree helps shape a more dynamic and efficient future for vaccine development and production.
