INSIGHTS ON REGULATORY COMPLIANCE
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![GettyImages-1136304110-blocks-steps-5]( "5 Steps To Completing A Successful Root Cause Analysis")
5 Steps To Completing A Successful Root Cause AnalysisDiscover how Root Cause Analysis transforms manufacturing by addressing underlying issues, improving quality, and preventing future failures, which empowers teams to move from reactive fixes to strategic solutions.
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![Cell Therapy Process Cevelopment Made Easy]( "Cell Therapy Process Development Made Easy")
Cell Therapy Process Development Made EasyExplore how Fast Trak™ process development services offered by Cytiva can guide you through achieving GMP compliance in your cell therapy manufacturing process.
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![GettyImages-1405217456-cleanroom-lab]( "A Driving Force For Advanced Cleanroom Standards")
A Driving Force For Advanced Cleanroom StandardsNavigating the inherent conflicts between GMP and biocontainment regulations is critical when designing specialized cleanrooms for advanced therapy manufacturing.
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![ISG crisis to confidence web thumb]( "From Crisis To Confidence: Ensuring Smooth Regulatory Submissions")
From Crisis To Confidence: Ensuring Smooth Regulatory SubmissionsExplore some of the major challenges that medical writing submission specialists face today and strategies that can consistently set the stage for success.
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Accelerating The Regulatory Approval Process Of Biosimilars5/13/2025
Leverage the power of pharmacodynamic biomarkers to streamline biosimilar development and accelerate regulatory approval with greater efficiency and confidence.
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Accelerated Tox Offerings: A Recipe For Streamlining IND Applications4/22/2025
Accelerating the timeline to tox material can significantly enhance the drug development process, enabling faster IND submissions and providing crucial time savings for toxicology studies.
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Successful Microbial Testing And Identification5/27/2025
In this presentation, one of our industry-leading customers discusses how they've successfully implemented the Applied Biosystems MicroSEQ Microbial Identification System in their laboratory testing.
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Trends In Next-Generation Delivery Technologies11/22/2023
Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.
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Achieving EU GMP Annex 1 Compliance For Contamination Control3/4/2025
Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-1483243079-doctors-data-computer-analysis-tablet-office]( "Combat Nitrosamine Challenges With Comprehensive Analytical Solutions")
As consumer safety becomes increasingly vital, the analysis of nitrosamine impurities in pharmaceuticals is critical. Classified as probable human carcinogens, nitrosamines pose significant health risks, prompting regulatory bodies like the U.S. Food and Drug Administration (FDA), Health Cananda and the European Food Safety Authority (EFSA) to implement strict guidelines.
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![GettyImages-1341291802 cleanroom]( "Partner With The Experts In Annex 1")
Prepare for Annex 1 compliance with expert-led support in contamination control, featuring solutions that cover risk assessment, validation, and training to ensure cleanroom safety and compliance.
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![MinicapProE]( "Remote Cleanroom Microbial Air Sampler (Annex 1-Compliant)")
The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).
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![GettyImages-1468373591-powder-dust]( "Process Safety, Dust Explosion Testing Capabilities")
Ensure safer, scalable chemical processes by integrating "Safety by Design" with expert process hazard analysis and robust risk mitigation from development through commercial manufacturing.
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![Pharma Manufacturing GettyImages-1135140594]( "Pharmaceutical Operational Readiness Programs")
Many Life Sciences companies struggle to minimize downtime, ensure safe operations, and reach tight production schedules while maintaining consistent, quality output in a demanding environment, but you can boost efficiency and reliability through our field-tested methodologies.
