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• A Complete Guide to Computer System Validation (CSV) | QbD Group
• A critical look at Annex 1: Manufacture of Sterile Medicinal Products
• A quality-focused process development roadmap for ATMPs
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• Case-studies

  • ATMP production sites commissioning & qualification | QbD Group
  • Enhancing data integrity & aseptic manufacturing compliance | QbD Group
  • Enhancing Sterilization Efficiency via Autoclave Validation | QbD Group
  • Ensuring a Smooth MDR Transition for Oystershell's Medical Devices | QbD Group
  • Ensuring pharmaceutical production quality: cleaning validation for government agency | QbD Group
  • Ensuring Timely Launch: QbD Group's Role in Establishing a Hemophilia Drug Production Line | QbD Group
  • Fast-Tracked Site Qualification for Clinical Trial Submission | QbD Group
  • Guiding KU Leuven's Glioblastoma Research to the Clinic with Precision Business Planning | QbD Group
  • Help BioLizard build their Quality Management System | QbD Group
  • Helping Abraca BioSystems to obtain ISO 13485 certification | QbD Group
  • Helping Relu to comply with changing regulations | QbD Group
  • How Lifestream Pharma Renewed Their CE Mark for BioXtra Under MDR
  • Optimizing Pharmacovigilance for a Biotechnology Leader | QbD Group
  • Patient support program (PSP) | QbD Group
  • Quickly bringing a new COVID-19 medical device to market | QbD Group
  • Revolutionizing pharmacovigilance: a success story of strategic partnership and seamless integration | QbD Group
  • Successful Clinical Evaluation supports rapid CE marking of Minze Health's Uroflowmeter | QbD Group
  • Supporting Oncomfort in developing and certifying their ISO 13485 QMS | QbD Group
  • The journey toward IVDR compliance for the LVOne device | QbD Group
• Case-study

  • Efficient Deviation Management for Timely Batch Release | Case Study
  • Scalable MSAT validation support for seamless compliance & efficiency
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• Quality by design methodology in the pharmaceutical industry
• Services

  • Pharmaceutical Lab Services Services | QbD Group

    • Cleaning Validation | Lab Sevices - QbD Group
    • Elemental Impurities | Lab Services - QbD Group
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    • Method Validation | Lab Services - QbD Group
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    • Tech Transfer | Our QualVal services - QbD Group
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    • IFUcare: Electronic IFU Solution for Medical Devices & IVD | QbD Group
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    • Paperless Validation | QbD Group
    • Scilife | QbD Group
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  • Your Trusted CRO for Medical Devices and IVD | QbD Group

    • Clinical Data Management Services | QbD Group
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    • Medical Writing for In Vitro Diagnostics | QbD Group
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    • Offerings - Clinical - Clinical Trial Operations
    • Post-Market Clinical Follow-up | QbD Group
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• Thank-you

  • Thank you for reaching out | QbD Group
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• Webinars

  • A unified MDSW development cycle that covers all requirements | QbD Group
  • A unified MDSW development cycle that covers all requirements | QbD Group
  • ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy | QbD Group
  • ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy | QbD Group
  • Comprehensive Market Access Strategies for Medical Device Software | QbD Group
  • Comprehensive Market Access Strategies for Medical Device Software | QbD Group
  • Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges | QbD Group
  • Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges | QbD Group
  • How to manage mandatory communication of toxicological risks | QbD Group
  • How to manage mandatory communication of toxicological risks | QbD Group
  • Overcoming Initial Obstacles in Medical Device Software Development | QbD Group
  • Overcoming Initial Obstacles in Medical Device Software Development | QbD Group
  • Pharmacovigilance and Risk Management in Innovative Therapies | QbD Group Webinar
  • Post-Market Surveillance requirements for Medical Devices and IVDs | QbD Group
  • Post-Market Surveillance requirements for Medical Devices and IVDs | QbD Group
  • Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems | QbD Group
  • Second edition of GAMP 5: A Risk-Based Approach to compliant GxP Computerized Systems | QbD Group
  • Technical Documentation Essentials for Medical Device Software | QbD Group
  • Technical Documentation Essentials for Medical Device Software | QbD Group
  • Unlocking strategic value in Drug Safety for Life Sciences organizations | QbD Group
  • Unlocking strategic value in Drug Safety for Life Sciences organizations | QbD Group
  • Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices | QbD Group
  • Webinar - 3D Printing in the Healthcare World | QbD Group
  • Webinar - Drug-Device Combination Products & Article 117 | QbD Group
  • Webinar - Drug-Device Combination Products & Article 117 | QbD Group
  • Webinar - Integrating Clinical Needs into Design & Documentation | QbD Group
  • Webinar - Integrating Clinical Needs into Design & Documentation | QbD Group
  • Webinar - IVDR Extension Explained: Tips & Strategies | QbD Group
  • Webinar - IVDR Extension Explained: Tips & Strategies | QbD Group
  • Webinar - Mastering Clinical Performance Studies under IVDR | QbD Group
  • Webinar - Mastering Clinical Performance Studies under IVDR | QbD Group
  • Webinar - Setting up ATMP Quality Management Systems: Strategies for Compliance and Success
  • Webinar - Setting up ATMP Quality Management Systems: Strategies for Compliance and Success
  • Webinar - The basic concepts of the QbD methodology
  • Webinar - The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body
  • Webinar - The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body
  • Webinar - Website storytelling: turning science into engagement | QbD Group
  • Webinar - Website storytelling: turning science into engagement | QbD Group
• Whitepaper-mdr-2017

  • Whitepaper: MDR 2017/745
• Whitepaper: Data integrity in the pharmaceutical industry
• Whitepaper: Mobile applications and compliancy: what you should know
• Whitepaper: Technology transfer
• Whitepaper: Technology Transfer Needs a Lingua Franca
• Whitepapers

  • 21 CFR Part 11 compliance checklist | QbD Group Whitepaper
  • A Complete Guide to Computer System Validation | QbD Group
  • A critical look at Annex 1: Manufacture of Sterile Medicinal Products
  • Achieving Laboratory Compliance | QbD Group Whitepaper
  • Analytical Method Validation | QbD Group Whitepaper
  • Clinical Evaluation for Medical Devices under MDR | QbD Group
  • Clinical Evidence for In Vitro Diagnostics under IVDR | QbD Group
  • Clinical investigations under MDR | QbD Group Whitepaper
  • Data integrity in the pharmaceutical industry
  • Digital Health - Exploring the landscape and future opportunities | QbD Group
  • Ensuring compliance and quality in Pharmacovigilance | QbD Group Whitepaper
  • EU GMP - How to import your products into the EU? | QbD Group
  • EUDRALEX Volume 4 Annex 11 Compliance Checklist | QbD Group Whitepaper
  • From V-model to Agile: how to embrace automation as part of the computerized system validation approach | QbD Group
  • GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations | QbD Group
  • GAMP categories for computerized systems | QbD Group
  • How to keep computerized systems in the operational phase | QbD Group
  • ICH Stability Studies on Pharmaceuticals | QbD Group Whitepaper
  • Innovations in ATMP: State of the industry in 2024 | QbD Group Whitepaper
  • ISO 13485:2016 - Compliance Checklist | QbD Group Whitepaper
  • IVDR Extension: What does this mean for you | QbD Group Whitepaper
  • Medical Device Regulation (MDR) Checklist | QbD Group
  • Mobile Health on the Rise: Exploring the Regulatory Landscape | QbD Group
  • New GMP facility qualification: set-up, process and best practices | QbD Group
  • Organic and Mutagenic Impurities in Pharma | QbD Group Whitepaper
  • Quality by design methodology in the pharmaceutical industry
  • Regulatory Affairs for Pharma and Biotech | QbD Group Flyer
  • Standards and regulations for Software used in Medical Devices | QbD Group
  • State-of-the-art Literature Review | QbD Group Whitepaper
  • Technology transfer
  • The key role of Regulatory Affairs in Pharma | QbD Group
  • The One-Vigilance Strategic Roadmap to corporate excellence | QbD Group
  • The pathway from idea to patient under MDR | QbD Group
  • Whitepaper: Technology Transfer Needs a Lingua Franca