INSIGHTS ON REGULATORY COMPLIANCE
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![03 West]( "Sample Sizes For Performance Testing Of Combination Products, Packaging")
Sample Sizes For Performance Testing Of Combination Products, PackagingWhen developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.
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![CAI - operational readiness webinar]( "The Pathway To Operational Readiness")
The Pathway To Operational ReadinessReady to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.
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![GettyImages-1388184871-quality-compliance-approval]( "A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk")
A Supplier-Manufacturer Approach To Mitigating Nitrosamine RiskLearn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
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![Document compliance, management, assessment-GettyImages-2208418097]( "GMP Compliance For Pharmaceuticals And Medical Devices")
GMP Compliance For Pharmaceuticals And Medical DevicesGood Manufacturing Practice (GMP) ensures products meet quality standards for their intended use, which covers all aspects of production. Explore how Ideagen supports GMP compliance across nine titles.
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Join Us At Summit CXO8/14/2025
Join top life sciences executives at Summit CXO, October 6–8 in Salt Lake City, for exclusive insights, expert speakers, and powerful networking that will elevate your leadership and strategic impact.
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Overcoming Excipient Risks And Challenges For Parenteral Formulations8/27/2025
Excipients are essential to parenteral formulations, which help protect APIs, enhance stability, and ensure safety. Learn how strategic excipient selection can optimize drug performance and patient outcomes.
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How Compounding Pharmacies Are Combating FDA Drug Shortages9/26/2024
Explore the global impact of pharmacy compounding, which plays a critical role in mitigating drug shortages and providing personalized medication solutions when commercial drugs are unavailable.
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Success Story: Increased Productivity With Concentrated Fed-Batch6/30/2025
Discover how a leading biopharma company boosted flexibility and quadrupled productivity by implementing a concentrated fed-batch process in a single-use facility.
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Modernizing Compendial SEC Methods For Biotherapeutics4/16/2024
Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.
REGULATORY COMPLIANCE SOLUTIONS
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![Regulatory compliance Getty Images-1256156511]( "Quality, Compliance, And Regulatory Services For Life Sciences")
The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
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![GettyImages-2024513353 drug manufacturing]( "Moving Visual Inspection Into Pharma 4.0 With The Identifier Software")
Move your visual inspection processes into the Pharma 4.0 era with a digital system that provides data integrity and full audit trails to aid in compliance.
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![GettyImages-1474854914-dashboard-hand-digital]( "Transform GMP Data Into Actionable Intelligence")
Explore a system that delivers real-time, compliance-ready analytics, which empowers teams with self-service dashboards, embedded reporting, and actionable calibration and maintenance data.
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![Intelligent Automation AI]( "Pharmaceutical Automation And Information Technology Services")
As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.
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![Doctor-Comforting-Patient-GettyImages-157718473]( "Clinical Pharmacology Services")
With over 30 years of proven experience, we provide comprehensive clinical pharmacology services, from data management and analysis to the generation of clinical study reports.
