INSIGHTS ON REGULATORY COMPLIANCE
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![2025 Trends Blog Cover Image]( "5 Trends Impacting CMOs In 2025")
5 Trends Impacting CMOs In 2025In 2025, CMOs will navigate Annex 1 compliance, the BioSecure Act’s uncertainty, AI-driven drug development, supply chain challenges from tariffs, and pandemic preparedness strategies.
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![WEST-Labs 168_ViewingQuarter-0052]( "Safely Navigating The Transition From MDD To MDR")
Safely Navigating The Transition From MDD To MDRIf devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.
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![GettyImages-2178829362-glp-1-protein-3d-render]( "Accelerating Method Development And Manufacturing Of GLP-1 Analogs")
Accelerating Method Development And Manufacturing Of GLP-1 AnalogsExplore a streamlined LC-UV/MS workflow that empowers labs to meet rising GLP-1 drug demand with faster, more informed decisions that enhance compliance and impurity detection efficiency.
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![GettyImages-1165109678-handshake-partner-business-agreement]( "MSD Global Digital Validation Rollout")
MSD Global Digital Validation RolloutSee how MSD digitized global validation processes achieved over 50% cycle time reduction, streamlined workflows, improved compliance, and enhanced remote collaboration during COVID-19.
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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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What Is The Position Of Regulatory Authorities On PUPSIT?5/2/2025
PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.
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Re-Engineering A Complex Process For FDA Compliance8/21/2024
Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.
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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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Electronic Batch Reporting1/22/2024
Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.
REGULATORY COMPLIANCE SOLUTIONS
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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.
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![HighByte Intelligence Hub]( "Solution Brief For Life Sciences")
Unlock the power of your industrial data with a scalable, edge-ready DataOps solution that contextualizes, standardizes, and secures data for enterprise-wide use.
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![GettyImages-1087218944 Scientists In Sterile Suits Working With Computers In The Laboratory]( "Quality Risk Management Software")
In the ever-evolving landscape of life science manufacturing, risk management is paramount to ensuring product quality, compliance, and timely market delivery. Meet MasterControl's Quality Excellence — your gateway to comprehensive and efficient quality risk management.
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![GettyImages-1370928101 regulatory compliance]( "Regulatory Affairs: Meeting The Highest Standards")
With a dedicated advisor supporting you from development through submission and commercialization, you’ll benefit from our proven track record in securing approvals across a wide range of modalities.
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![Class 2 Biological Safety Cabinet Type A2]( "Class 2 Biological Safety Cabinet")
The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.
