INSIGHTS ON REGULATORY COMPLIANCE
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A New Framework For Identifying Nitrosamine Risks And Derisking Products
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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5 Drug Manufacturing Trends To Look For In 2025
The life sciences industry faces big changes in 2025. Companies must adapt to new regulations, AI, and shifting manufacturing landscapes to stay competitive and drive innovation.
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Compliance To Confidence: Annex 1 For Small-Batch, High-Value Production
Get strategies for meeting the updated GMP Annex 1 in small-batch aseptic filling. Learn about contamination control, quality management, and equipment design for high-value liquid and powder products.
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A Compact, Flexible, And Easy To Use Benchtop Mixer
Compact, flexible, and easy to use, this benchtop mixer supports volumes from 100 mL to 10 L with integrated sensing options and GxP-compatible software, ideal for efficient, reproducible mixing.
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Visual Inspection Of Advanced Therapy Medicinal Products9/2/2025
Discover how expert database systems for inspection defect management and control help cell and gene therapies meet the requirements of USP-790 to assure they are essentially free from particulate matter.
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Top 3 Mistakes Companies Make During Sterilization Validation5/27/2025
Sterilization validation is essential for product safety and compliance. Discover the top three mistakes companies make and learn practical strategies to avoid delays, non-compliance, and patient safety risks.
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Why The Latest Technology Helps Navigate Evolving Regulator Expectations11/27/2024
By embracing data-driven insights, companies can confidently navigate complexities, reduce risks, and deliver trusted products to global markets.
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Project Management: The Secret Weapon In Effective Tech Transfer5/23/2024
Explore how a CMO with innovative practices and a successful approach to tech transfer and manufacturing processes can help meet project timelines and mitigate risk on the path to market.
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The Evolution Of EAM/CMMS In Pharma Manufacturing8/8/2025
Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.
REGULATORY COMPLIANCE SOLUTIONS
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Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.
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This useful tool helps to ensure quality and safety in cell therapy products through the use of a probe-based quantitative PCR (qPCR) assay to detect bacterial and fungal species.
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The journey of a GLP-1 receptor agonist (GLP-1 RA) molecule is complex.
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Examine a scalable, benchtop mixing system designed for sensitive fluids and GxP environments that supports automated control, traceability, and compliance from early development through production.
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Effective inventory management ensures the quality and traceability of raw materials, supports regulatory compliance, and enables operational savings. Learn how to secure your supply chain and reduce stockouts.