GxP Consulting Services

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class="row justify-content-between align-items-center"> <div class="col-12 col-sm-6 px-3 ps-sm-0 pe-sm-2 my-sm-5 py-5"> <h1 class="text-light-blue display-4 fw-semi-bold"> GxP Consulting Services </h1> <p class="mt-sm-4 mt-4 text-white jumbotron__subtext"> ValGenesis Consulting combines industry experience and process mastery to help you transform your business to deliver life-saving products to market with higher speed, quality, and confidence. </p> <p class="mb-0 mt-4 mt-sm-5"> <button class="cta cta-loud" data-bs-toggle="modal" data-bs-target="#talktoourexperts_jumbotron" role="button">Talk to Our Experts</button> </p> </div> </div> </div> <div class="jumbotron__color-overlay"></div> </div> <div class="modal fade" id="talktoourexperts_jumbotron" tabindex="-1" role="dialog" aria-labelledby="talktoourexperts_jumbotron" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered" role="document"> <div class="modal-content"> <div class="modal-header"> <h5 class="modal-title h5 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class="py-section py-sm-section px-3 ps-md-5" style="max-width: 646px;"> <span id="hs_cos_wrapper_challenges_intro_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="rich_text"><h2>Meet Challenges. Unlock Opportunities.</h2> <p>In the life sciences, change is constant. Agility and continuous improvement are what separate good companies from great ones. Achieving operational excellence in the face of regulatory challenges and lengthy development cycles is difficult for any team.</p> <p>The experts of ValGenesis Consulting understand the unique challenges of your industry. Every day, around the world, our discerned insights shape the strategies that enable life sciences companies — from premarket start-ups to multisite global corporations — to bring discipline to operations, clarity to processes, and foresight to technology investments. The result? Solving today’s problems while rising toward tomorrow’s possibilities.</p></span> </div> </div> </div> </div>  <div class="container-fluid pt-sm-section"> <div class="container py-section py-sm-section px-sm-0"> <div class="row"> <div class="col-12 col-lg-5 pe-lg-5 mb-4 mb-lg-0"> <span id="hs_cos_wrapper_services_intro_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="rich_text"><h2>From Concept to Commercialization</h2> <p>Our consulting services impact all phases of the product and process lifecycle, from R&D through commercial operations.</p> <p>And because they’re process-based, any regulated organization, regardless of the enterprise systems they use, can benefit from our multidisciplinary approach.</p></span> </div> <div class="col-12 col-lg-7"> <h4 class="px-lg-4 text-medium-gray mb-2"> <span id="hs_cos_wrapper_accordion_header_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="text">We offer guidance in three core focus areas:</span> </h4> <div class="accordion accordion-flush" id="phaseDescriptions"> <div class="accordion-item"> <h2 class="accordion-header" id="headingOne"> <button class="accordion-button collapsed" type="button" data-bs-toggle="collapse" data-bs-target="#tabOne" aria-expanded="false" aria-controls="tabOne"> <div class="d-flex align-items-center" style="flex-grow: 1;"> <div class="d-none d-lg-block" style="width: 100px"> <img class="img-fluid" src="https://www.valgenesis.com/hubfs/vg-theme/vg-consulting/icons/icons-consulting-01.png" loading="lazy"> </div> <div class="w-100 h5 text-dark-blue mb-0 ps-lg-3"> <span id="hs_cos_wrapper_accordion_title_tab1_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="text">Product and Process Lifecycle</span> </div> </div> </button> </h2> <div id="tabOne" class="accordion-collapse collapse" aria-labelledby="headingOne" data-bs-parent="#phaseDescriptions"> <div class="accordion-body"> <span id="hs_cos_wrapper_accordion_desc_tab1_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="rich_text"><p>Efficient processes empower you to function at a higher level. Leverage our data-driven insights to optimize resource usages, improve operations, enhance decision-making, and drive real results while containing the costs of compliance.</p> <ul> <li>Early-phase drug screening with machine learning</li> <li>Quality by Design (QbD)/retrospective QbD implementation support</li> <li>Scale-up and technology transfer</li> <li>Data science-driven process design, optimization, and understanding</li> <li>Process troubleshooting</li> <li>Process simulation with digital twins</li> </ul></span> </div> </div> </div> <div class="accordion-item"> <h2 class="accordion-header" id="headingTwo"> <button class="accordion-button collapsed" type="button" data-bs-toggle="collapse" data-bs-target="#tabTwo" aria-expanded="false" aria-controls="tabTwo"> <div class="d-flex align-items-center" style="flex-grow: 1;"> <div class="d-none d-lg-block" style="width: 100px"> <img class="img-fluid" src="https://www.valgenesis.com/hubfs/vg-theme/vg-consulting/icons/icons-consulting-02.png" loading="lazy"> </div> <div class="w-100 h5 text-dark-blue mb-0 ps-lg-3"> <span id="hs_cos_wrapper_accordion_title_tab2_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="text">Quality Risk Management (QRM)</span> </div> </div> </button> </h2> <div id="tabTwo" class="accordion-collapse collapse" aria-labelledby="headingTwo" data-bs-parent="#phaseDescriptions"> <div class="accordion-body"> <span id="hs_cos_wrapper_accordion_desc_tab2_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="rich_text"><p>Every product or process has associated risks. We partner with you to identify, qualify, and prioritize risks so that you can build risk mitigation strategies throughout the lifecycle of your products, equipment, facilities, suppliers, analytical methods, and other assets and activities. We’ll help you advance your existing QRM practices by leveraging the power of your data to enhance decision-making and anticipate and respond to risk more effectively.</p> <ul> <li>Strategic QRM maturity programs</li> <li>ICH Q9 (R1) compliance assessment services</li> <li>Data-driven risk management programs</li> <li>Risk management facilitation</li> <li>Risk management training</li> </ul></span> </div> </div> </div> <div class="accordion-item"> <h2 class="accordion-header" id="headingThree"> <button class="accordion-button collapsed" type="button" data-bs-toggle="collapse" data-bs-target="#tabThree" aria-expanded="false" aria-controls="tabThree"> <div class="d-flex align-items-center" style="flex-grow: 1;"> <div class="d-none d-lg-block" style="width: 100px"> <img class="img-fluid" src="https://www.valgenesis.com/hubfs/vg-theme/vg-consulting/icons/icons-consulting-03.png" loading="lazy"> </div> <div class="w-100 h5 text-dark-blue mb-0 ps-lg-3"> <span id="hs_cos_wrapper_accordion_title_tab3_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="text">Chemistry, Manufacturing and Controls (CMC) Strategy</span> </div> </div> </button> </h2> <div id="tabThree" class="accordion-collapse collapse" aria-labelledby="headingThree" data-bs-parent="#phaseDescriptions"> <div class="accordion-body"> <span id="hs_cos_wrapper_accordion_desc_tab3_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="rich_text"><p>Navigate the path from product concept to market delivery with confidence. We’ll help you build a comprehensive CMC strategy that can withstand regulatory scrutiny and ensure the quality, safety, efficacy, and consistency of your products and processes.</p> <ul> <li>Lab-to-market acceleration</li> <li>Digitalization</li> <li>Strategic validation and continuous process verification programs</li> </ul></span> </div> </div> </div> </div> </div> </div> </div> </div> <div id="hs_cos_wrapper_module_16830799904577" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><div class="container-fluid py-section py-sm-section"> <div class="container border rounded bg-ultralightgray p-3 p-lg-5"> <div class="row mb-4 mb-lg-5"> <div class="col-lg-6"> <h2>Bring your vision to life sooner with GxP Jumpstart Packages</h2> <p class="h5">Reach your business and development goals faster with our predefined consulting offerings. Each GxP Jumpstart Package includes assessments, plan development, access to proprietary technology, and structured project management.</p> </div> <div class="col-lg-6"> <p>Our team of engineers, scientists, strategists, and problem solvers will work alongside your team to implement a standardized process methodology that is compliant, efficient, and scalable, then show you how to replicate that proven methodology seamlessly throughout your broader product or system portfolio.</p> <p>GxP Jumpstart Packages are based on current regulatory guidelines and industry best practices. Their outcomes are designed to accelerate innovation, drive efficiency, optimize manufacturing, and shorten time to market.</p> <p>GxP Jumpstarts are an ideal introduction to our services and can be customized to meet project complexity and client needs.</p> </div> </div> <div class="row"> <div class="col-12 col-lg-4 mb-3 mb-lg-0"> <a href="" class="gxp-jumpstart-button d-block rounded text-center d-flex justify-content-center align-items-center p-3 bg-white" data-bs-toggle="modal" data-bs-target="#cpv"> <div> <img src="https://www.valgenesis.com/hubfs/vg-theme/vg-consulting/gxp%20jumpstart%20packages/cpv.webp" class="img-fluid mb-3" loading="lazy" alt="CPV"> <h5>CPV</h5> </div> </a> </div> <div class="modal fade" id="cpv" tabindex="-1" aria-labelledby="cpvLabel" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered modal-lg"> <div class="modal-content"> <div class="modal-header"> <h5 class="modal-title" id="cpvLabel">Continued Process Verification</h5> <button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close"></button> </div> <div class="modal-body"> <p>CPV aims to verify that a production process remains in a state of control during commercial manufacturing. It requires precise data collection and analysis to identify product or process issues. Creating a detailed plan for monitoring the manufacturing process is a significant challenge. This GxP Jumpstart Package will help you understand the data analytics and science behind CPV and develop a plan to future-proof your process verification systems.</p> <h5>Deliverables:</h5> <ul> <li>A risk-based CPV plan for one selected product</li> <li>Process monitoring results at defined intervals for a defined number of batches (based on the selected product)</li> <li>Access to ValGenesis iRisk and Process Insight products to visualize the risk assessment, CPV plan, and monitoring data and CPV report (for the selected product)</li> <li>A CPV methodology that can be replicated throughout the product portfolio</li> </ul> </div> </div> </div> </div> <div class="col-12 col-lg-4 mb-3 mb-lg-0"> <a href="" class="gxp-jumpstart-button d-block rounded text-center d-flex justify-content-center align-items-center p-3 bg-white" data-bs-toggle="modal" data-bs-target="#technologytransfer"> <div> <img src="https://www.valgenesis.com/hubfs/vg-theme/vg-consulting/gxp%20jumpstart%20packages/technology-transfer.webp" class="img-fluid mb-3" loading="lazy" alt="Technology Transfer"> <h5>Technology Transfer</h5> </div> </a> </div> <div class="modal fade" id="technologytransfer" tabindex="-1" aria-labelledby="technologytransferLabel" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered modal-lg"> <div class="modal-content"> <div class="modal-header"> <h5 class="modal-title" id="technologytransferLabel">Technology Transfer</h5> <button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close"></button> </div> <div class="modal-body"> <p>Adequately balancing risk, regulatory expectations, aggressive go-to-market timelines, and the increased transfer volume between teams, sites, and organizations demands an efficient methodology to prevent development bottlenecks. This GxP Jumpstart Package aligns traditional tech transfer principles with a strong risk management focus and leverages modeling (e.g., first principles, mechanistic, hybrid) and advanced data science tools to streamline your tech transfer implementation throughout the product lifecycle.</p> <h5>Deliverables:</h5> <ul> <li>Tech transfer risk gap assessment</li> <li>Tech transfer plan</li> <li>Tech transfer tasks execution (e.g., scale-up/scale-down/scale-out support, process modeling)</li> <li>Tech transfer report</li> <li>Continued project management support with executive status progression reports</li> <li>A tech transfer methodology that can be replicated throughout the organization </li> </ul> </div> </div> </div> </div> <div class="col-12 col-lg-4"> <a href="" class="gxp-jumpstart-button d-block rounded text-center d-flex justify-content-center align-items-center p-3 bg-white" data-bs-toggle="modal" data-bs-target="#csvtocsa"> <div> <img src="https://www.valgenesis.com/hubfs/vg-theme/vg-consulting/gxp%20jumpstart%20packages/csv-csa.webp" class="img-fluid mb-3" loading="lazy" alt="CSV to CSA"> <h5>CSV to CSA</h5> </div> </a> </div> <div class="modal fade" id="csvtocsa" tabindex="-1" aria-labelledby="csvtocsaLabel" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered modal-lg"> <div class="modal-content"> <div class="modal-header"> <h5 class="modal-title" id="csvtocsaLabel">Computer System Validation to Computer Software Assurance</h5> <button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close"></button> </div> <div class="modal-body"> <p>Computer software assurance, the FDA’s new framework for performing CSV, encourages us to take a risk-based, least burdensome approach using critical thinking and unscripted testing methods. While the promise of simplified, less costly validation is exciting, many companies are confused about how to adopt the new framework. This GxP Jumpstart Package will show you how to implement a standardized CSA methodology and reclaim the quality-centric mindset lost in the document-centric CSV approach.</p> <ul> <li>CSV to CSA gap assessment</li> <li>CSA project plan</li> <li>CSA-ready procedures and work instructions</li> <li>Validation of one system using the CSA framework</li> <li>Access to ValGenesis iRisk and VLMS products to visualize risk assessment and validation execution with customer data</li> <li>A CSA methodology that can be replicated throughout the organization</li> </ul> </div> </div> </div> </div> </div> </div> </div></div>  <div class="container-fluid"> <div class="container py-section py-sm-section"> <div class="row justify-content-center align-items-start text-center pb-5"> <div class="col-12"> <h2 class="fw-semi-bold text-dark-blue mb-0"> <span id="hs_cos_wrapper_module_16776666447007_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="text">Our Experts Are the Best at What They Do.</span> </h2> </div> </div> <div class="row justify-content-center align-items-start"> <div class="col-12 col-sm-8 text-sm-center"> <span id="hs_cos_wrapper_team_intro_text_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_rich_text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="rich_text"><p>Our team of industry experts possesses a thorough understanding of global regulations and the trends shaping the future of life sciences businesses. This knowledge, coupled with unmatched technical expertise, will help you refine your operational processes and go-to-market strategies to accelerate growth. Consultants bring 10+ years of international real-world expertise to your project.</p></span> </div> </div> <div class="row justify-content-center text-center pt-5 px-lg-5"> <div class="col-12 col-sm-4 p-4 px-lg-5"> <a href="/hello/daniel-pais" rel="noopener" target="_blank" class="d-block mb-4"> <img class="img-fluid rounded-circle headshot-hover" src="https://www.valgenesis.com/hubfs/People/00-webp/daniel-pais.webp" alt="Daniel Pais" style="max-width: 200px"> </a> <div class="d-flex justify-content-center"> <span class="d-inline-block me-2">Daniel Pais</span> <a href="https://www.linkedin.com/in/danielampais/" class="text-dark-blue" rel="noopener"><i class="bi bi-linkedin text-dark-blue"></i></a> </div> <p class="small my-2"> Senior Consultant </p> <span class="text-medium-gray text-vg-smaller"> Process Modelling </span> <span class="text-medium-gray text-vg-smaller"> <span class="text-light-blue d-inline-block mx-1">|</span> Cell and Gene Therapy and other ATMPs </span> </div> <div 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class="d-inline-block me-2">Inês Victorino</span> <a href="" class="text-dark-blue" rel="noopener"><i class="bi bi-linkedin text-dark-blue"></i></a> </div> <p class="small my-2"> Associate Consultant </p> <span class="text-medium-gray text-vg-smaller"> Data Science </span> </div> <div class="col-12 col-sm-4 p-4 px-lg-5"> <a href="/hello/margarida-ventura" rel="noopener" target="_blank" class="d-block mb-4"> <img class="img-fluid rounded-circle headshot-hover" src="https://www.valgenesis.com/hubfs/People/00-webp/margarida-ventura.webp" alt="Margarida Ventura" style="max-width: 200px"> </a> <div class="d-flex justify-content-center"> <span class="d-inline-block me-2">Margarida Ventura</span> <a href="https://www.linkedin.com/in/anamargarida-ventura/" class="text-dark-blue" rel="noopener"><i class="bi bi-linkedin text-dark-blue"></i></a> </div> <p class="small my-2"> Senior Consultant </p> <span class="text-medium-gray text-vg-smaller"> QRM </span> </div> <div class="col-12 col-sm-4 p-4 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class="d-inline-block me-2">Rui Almeida</span> <a href="https://www.linkedin.com/in/rui-estrela-almeida-pmp-5745056/etr" class="text-dark-blue" rel="noopener"><i class="bi bi-linkedin text-dark-blue"></i></a> </div> <p class="small my-2"> Director - Consulting Services </p> <span class="text-medium-gray text-vg-smaller"> PLCM </span> <span class="text-medium-gray text-vg-smaller"> <span class="text-light-blue d-inline-block mx-1">|</span> CMC Strategy </span> </div> <div class="col-12 col-sm-4 p-4 px-lg-5"> <a href="/hello/rui-silva" rel="noopener" target="_blank" class="d-block mb-4"> <img class="img-fluid rounded-circle headshot-hover" src="https://www.valgenesis.com/hubfs/People/00-webp/rui-silva.webp" alt="Rui César Silva" style="max-width: 200px"> </a> <div class="d-flex justify-content-center"> <span class="d-inline-block me-2">Rui César Silva</span> <a href="https://www.linkedin.com/in/rsilva1809/" class="text-dark-blue" rel="noopener"><i class="bi bi-linkedin 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class="small my-2"> Vice President, Consulting Services </p> <span class="text-medium-gray text-vg-smaller"> PLCM </span> <span class="text-medium-gray text-vg-smaller"> <span class="text-light-blue d-inline-block mx-1">|</span> CMC Strategy </span> <span class="text-medium-gray text-vg-smaller"> <span class="text-light-blue d-inline-block mx-1">|</span> QRM </span> </div> </div> </div> </div>  <div class="container-fluid"> <div class="container py-section py-sm-section"> <div class="row justify-content-center align-items-start text-center pb-5"> <div class="col-12"> <h2 class="fw-semi-bold text-light-blue mb-0"> <div id="hs_cos_wrapper_module_167766816725610" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_module widget-type-text" style="" data-hs-cos-general-type="widget" data-hs-cos-type="module"><span id="hs_cos_wrapper_module_167766816725610_" class="hs_cos_wrapper hs_cos_wrapper_widget hs_cos_wrapper_type_text" style="" data-hs-cos-general-type="widget" 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