INSIGHTS ON REGULATORY COMPLIANCE
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![Getty Images 1210343139 TMF]( "Round 2: Mastering NDA Submission And A Resubmission Rescue Mission")
Round 2: Mastering NDA Submission And A Resubmission Rescue MissionThis biopharmaceutical company had to overcome trial master file (TMF) transfer from a previous licensee, staff turnover, and then a resubmission of its NDA.
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![GettyImages-1322205575 data ps]( "How Modern EQMS Solutions Are Powering Pharma’s Digital Revolution")
How Modern EQMS Solutions Are Powering Pharma’s Digital RevolutionIf your company isn’t at least planning on implementing an EQMS solution or other advanced digital tools, learn why now is the time to start.
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![Spray Bottle GettyImages-1207505640]( "Alcohols For Use As An Antimicrobial Agent")
Alcohols For Use As An Antimicrobial AgentCare must be taken when determining the use of alcohols in any controlled environment. Learn about the many useful and practical properties of alcohols along with important regulations.
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![Chromatography GettyImages-1392302602]( "Extractables And Leachables: Risk Management And Analytical Solutions")
Extractables And Leachables: Risk Management And Analytical SolutionsPartnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.
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Sterile Filtration And Quality Risk Management8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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Regulatory And Quality Consulting, Operational Readiness Services10/5/2023
Learn how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility.
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Navigating EU GMP Annex 1 Revisions In Drug Manufacturing11/27/2023
Explore changes introduced by the revised EU GMP Annex 1, key considerations to maintain compliance, and stark statistics that underscore the consequences of non-compliance in this evolving landscape.
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The Chemistry Of Aqueous Cleaning4/26/2023
In this chapter of The Aqueous Cleaning Handbook, we explore the key definitions of aqueous cleaner ingredients, the types of aqueous cleaners, and the application of isoelectric points to cleaning.
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How To Prepare For An Inspection: 8 Tips For Success3/15/2024
To achieve a successful inspection, organizations should adopt best practices. Examine these eight invaluable tools for inspection success.
REGULATORY COMPLIANCE SOLUTIONS
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![CAI]( "Pharmaceutical Asset Management & Reliability Services")
Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.
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![iStock-941351188-lab-cleanroom-sterile]( "Out Of Specification (OOS) Software For Life Sciences")
The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.
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![GettyImages-1434150674-lab-microscope-team]( "Integrated Drug Discovery")
Finding a partner with integrated services is crucial for accelerating timelines and accessing solutions with comprehensive expertise, all while removing risk from the drug product lifecycle.
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![SpeedAir 3050]( "Enhance Product Safety With A Non-Destructive Leak Testing System")
Versatile CCIT1 for a wide range of applications
The SpeedAir 3050 is your all-in-one solution for nonporous pharmaceutical applications. Whether your products are flexible or rigid, liquid or solid, the SpeedAir 3050 can swiftly and accurately test them all. With testing times as short as 30-45 seconds, it delivers results you can rely on, ensuring the integrity of your pharmaceutical containers.
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![Collaborate beside image]( "Regulatory Services Offering")
Navigating the path toward regulatory approval is a complex process. Learn how partnering with Societal™ CDMO and leveraging regulatory expertise can empower your organization to achieve its goals.
