INSIGHTS ON REGULATORY COMPLIANCE
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![Inspection scientist GettyImages-1180581833]( "Building A High-Fidelity Manual Baseline For Tomorrow's Automated Inspection")
Building A High-Fidelity Manual Baseline For Tomorrow's Automated InspectionFuture-proof your pharma manufacturing. Discover why manual visual inspection remains foundational and how advanced software can build a high-fidelity baseline for automation success.
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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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![GettyImages-2163506576-computer-ai-compliance-regulatory]( "Ensuring AI Compliance In Life Sciences: 5 Critical Requirements")
Ensuring AI Compliance In Life Sciences: 5 Critical RequirementsLife sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.
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![West_CZ Insert Needle 115860aw 11569_RGB_2]( "Designing Robust Studies To Meet Auto-Injector Performance Requirements")
Designing Robust Studies To Meet Auto-Injector Performance RequirementsLearn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.
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Navigating Digital Transformation For Pharmaceutical CDMOs10/31/2025
Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.
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4 Conversations To Drive Your Business Case For Digital Validation3/19/2025
Change in life sciences is challenging due to strict regulations, high stakes, and the importance of patient safety. Learn how to advocate for digital validation workflows through four key conversations.
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Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics5/16/2025
All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.
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Managing Complex Data In Process Development And CMC11/12/2025
Learn how automated platforms streamline data capture, integration, and analysis—enabling better decisions, improved consistency, and faster workflows across CMC and process development.
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How Can You Avoid Bioprocessing Risks When Using Cable Ties?10/15/2025
Cable ties in bioprocessing can cause leaks, damage, and delays. See how switching to a uniform-sealing connector can significantly improve efficiency, reduce prep time, and minimize contamination risks.
REGULATORY COMPLIANCE SOLUTIONS
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![SoftmaxProGxp]( "Meet Regulatory Guidelines In GMP/GLP Labs With SoftMax Pro GxP Software")
Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation
SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.
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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.
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![LevMixer™]( "A Scalable, Benchtop Mixing System For Sensitive Fluids")
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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![503B drug compounding]( "Cleanrooms And Equipment For 503B Outsourcing Facilities")
Germfree understands the unique challenges associated with 503B sterile drug compounding
Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.
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![Pharm Manufacturing Facility GettyImages-1087218874]( "Technology Transfer And Commercial Manufacturing Of Tablets And Capsules")
Finding a strategic CDMO partner that will offer tailored solutions for your late phase clinical and commercial needs, mitigate risks, and bolster your supply chain is crucial for meeting project milestones on time.
