INSIGHTS ON REGULATORY COMPLIANCE
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![rules, policies, regulatory documents-GettyImages-1438925546]( "Compliance with Annex 1: Sterile Fill/Finish for Early Phase Clinical Supplies")
Compliance with Annex 1: Sterile Fill/Finish for Early Phase Clinical SuppliesGrasp the strategies for Annex 1 compliance, focusing on Contamination Control Strategy, Pre-Use Post Sterilization Integrity Testing, and critical zone controls to secure aseptic manufacturing processes.
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![GettyImages-1322057206-self-injection-device-delivery]( "De-Risking The Transition From Vial To Drug-Device Combination Product")
De-Risking The Transition From Vial To Drug-Device Combination ProductWhen transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.
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![Ensuring quality in document review]( "Strategies For QA Professionals In Life Sciences")
Strategies For QA Professionals In Life SciencesExplore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.
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![Compliance Regulation Business Technology risk management-GettyImages-1433535736]( "What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry?")
What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry?The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the pharmaceutical industry to strategize to achieve the best compliance method.
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Move Beyond Manual CQV Challenges With Digital Solutions1/24/2025
Review how digitalizing commissioning, qualification, and validation (CQV) with a new software streamlines processes, enhances compliance, and reduces time to drive efficiency and sustainability.
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Optimized Expression Systems For Increased Productivity8/7/2025
Discover innovative strategies to boost CHO DG44 cell line productivity, as well as explore optimized expression systems that enhance yield, stability, and efficiency in protein development.
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Advancing QC Efficiency With SEC-MALS System And Empower Software7/31/2025
Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.
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Rethinking Sustainability In Bioprocessing5/22/2025
Discover how sustainability is transforming bioprocessing through innovative single-use technologies that help reduce environmental impact and support responsible, forward-thinking biomanufacturing.
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How Bend Bioscience Standardized Operations And Boosted Compliance8/8/2025
Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.
REGULATORY COMPLIANCE SOLUTIONS
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![GettyImages-950086574-microscope-scientist-pill-development]( "Developing Pediatric Formulations")
From safety considerations to kid-friendly dosing, we can help you get your pediatric formulation right.
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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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![digital transformation-Digitization of Analog Information-GettyImages-867312356]( "A Leading Digital Validation Platform For Life Sciences")
Discover Kneat Gx, a leading digital validation platform trusted by top Life Sciences companies, reducing validation time and costs while enhancing compliance, scalability, and efficiency.
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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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![GettyImages-968924932 Industrial engineers with tablet in a factory checking documents]( "The Industrial DataOps Solution For Industry 4.0")
HighByte Intelligence Hub is a DataOps software solution purpose-built for industrial data. The Intelligence Hub enables manufacturers to securely connect, model, condition, and flow valuable industrial data to and from IT systems without writing or maintaining code. The software is deployed at the Edge to merge real-time, transactional, and time-series data into a single payload for consuming applications.
With the Intelligence Hub, users can speed system integration time, rapidly leverage contextualized data for analytics, AI, and ML applications, and govern data standards across the enterprise. HighByte Intelligence Hub provides the critical data infrastructure for Pharma 4.0.
