INSIGHTS ON REGULATORY COMPLIANCE
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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China
Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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Biopharma Supply, Reimagined: Blarney, A Climate-Neutral Facility For Best-In-Class Filters
Explore how a new, climate-neutral manufacturing facility strengthens biopharma supply chains. Understand the benefits of its advanced filtration technologies and commitment to environmental sustainability.
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Managing Risks In Injectable Drug Delivery
Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.
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Simplify CAPA In 7 Steps
Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.
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Navigating The Regulatory Space To Biosimilar Approval9/1/2025
The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.
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The Evolution Of GMP Asset Management10/31/2025
Learn how teams are shifting from reactive maintenance to predictive intelligence with connected systems, real-time insights, and AI-driven asset strategies while keeping compliance at the center.
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Ethylene Oxide For Industrial Sterilization: Part 29/9/2025
Sterilization process development ensures product safety and compliance through optimized cycles. Learn how biological indicators and process challenge devices strengthen your sterilization strategy.
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A New Approach To Isolator Decontamination4/8/2024
How can you address the decontamination challenges associated with isolated fill-finish operations? New innovations are being implemented to ensure superior sporicidal reduction and operational safety.
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Enhancing Viral Vector Sterile Filtration: Process Efficiency And GMP Alignment11/4/2025
Explore filtration strategies that improve viral vector yield and quality, with insights on AAV and lentivirus workflows, plus practical guidance for implementing PUPSIT in line with requirements.
REGULATORY COMPLIANCE SOLUTIONS
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Ensure your products and materials maintain integrity through distribution with robust package validation testing. Explore comprehensive capabilities including simulation and aging tests.
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From risk assessment to bio-decontamination solutions, drive continuous improvement in contamination control with tailored expert support.
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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.
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Review data collection system, software, and controls that should be considered with each institution's policies and procedures to achieve compliance with 21 CFR Part 11.
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Ensure patient safety and product efficacy with high-quality pharmaceutical excipients that are designed to streamline regulatory approval and support sterile liquid drug formulation development.