INSIGHTS ON REGULATORY COMPLIANCE
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![White Raven's Accelerated Path To GMP Certification Splash]( "White Raven's Accelerated Path To GMP Certification")
White Raven's Accelerated Path To GMP CertificationCDMO White Raven achieved GMP certification using an innovative aseptic filling solution in just 18 months. Discover how meticulous planning and collaboration set a new industry standard for efficiency.
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![ADC_Main_Visual_450_300]( "Analytical Strategies For Impurity Control In Antibody-Drug Conjugates")
Analytical Strategies For Impurity Control In Antibody-Drug ConjugatesAntibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.
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![GettyImages-1214921728-lab-glassware-beaker-vial-test-tube]( "Aggregation In Antibody-Drug Conjugates: Causes And Mitigation")
Aggregation In Antibody-Drug Conjugates: Causes And MitigationDiscover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.
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![GettyImages-1617924079-hand-milestone-steps-achieve]( "A 5-Step Guide To Achieving Your Biosimilar Milestones On Time")
A 5-Step Guide To Achieving Your Biosimilar Milestones On TimeAs the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.
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Why Choose The Identifier Software?7/18/2025
Unlock Pharma 4.0 for injectable drug inspection. Learn about a system that transforms data management, offering immediate access and global regulatory compliance.
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How To Overcome Common Single-Use Assembly Design Challenges10/15/2025
Single-use systems offer major benefits in pharma manufacturing, but design complexity brings challenges. Learn how to overcome issues like scalability and quality assurance with integrated strategies.
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Visualizing Airflow With Smoke Studies For Aseptic Manufacturing Excellence7/7/2025
JHS uses smoke studies to visualize airflow in cleanrooms, ensuring aseptic conditions and regulatory compliance for sterile pharmaceutical production, especially on new aseptic filling lines.
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Comprehensive Regulatory Support8/29/2024
Review our expertise across a wide range of global markets. Our experience in securing regulatory approvals and navigating market challenges positions us as a trusted partner.
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Deviation And Change Control In Pharmaceutical Manufacturing9/20/2024
Explore deviation management and change control in the pharmaceutical industry, the elements of Corrective and Preventive Action (CAPA), and how to best approach these three interconnected processes.
REGULATORY COMPLIANCE SOLUTIONS
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![iStock-1002126898-graph-tablet-meeting-risks-planning]( "Ensuring Compliance, Improving Efficiency, And Accelerating Time To Market With QMS Software")
A lot of companies see quality management as a process that puts the brakes on progress. We’re here to change that. MasterControl QMS software will help you digitize and automate every step of quality management. We’ll help you eliminate the hassles, inefficiencies, and paper of your current system. Then you can get your products to market faster.
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![GettyImages-1327977866-cell-culture-sample-laboratory]( "Powering Production Of Viral Vector-Based Therapies")
Gene therapies hold immense potential to provide long-lasting treatments for a wide range of diseases. At Cytiva, we offer GMP-compliant, end-to-end manufacturing solutions designed to support the development and commercialization of advanced medicines across multiple modalities – including AAV, adenovirus (AV), lentivirus (LV), plasmid DNA (pDNA) and exosomes. Our dependable suite of technologies and expertise ensures scalability, quality, and regulatory confidence at every stage of your journey.
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![Cell Therapy]( "Cleanrooms And Equipment For Cell Therapy Drug Manufacturing")
Delivering on the promise of cell and gene therapy through Germfree products and services.
Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.
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![TouchTools™]( "Programming Simplicity And Operational Consistency At Your Fingertips")
Streamline your lab automation with a customizable touchscreen, dynamic programming, and real-time monitoring to boost productivity, minimize errors, and integrate data across workflows.
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![Compliance-virtual-diagram-GettyImages-1370928101]( "Compliance Program For EU Annex 1 Container Closure Requirements")
Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.
