A mid-size biotech company faced critical FDA remediation and clinical milestones. By partnering with GQR, they rapidly upscaled their quality and regulatory teams, meeting tight timelines and stringent compliance standards. Key Achievements: ๐น 95% Fill Rate: Rapidly deployed specialized talent ๐น 90% Contractor Retention: Ensured project continuity ๐น FDA Remediation and Clinical Milestones Met ๐น Strengthened Regulatory Position Our tailored talent solutions foster growth and innovation, helping our partners meet their strategic goals. Interested in learning more about how we can support your talent acquisition needs? Reach out to our Life Sciences team today ๐ https://lnkd.in/gwctZiGD #GQRlifesciences #GQR #GQRinsights Nicole Leinders Hannah Roberts Luke S. Trevor Symons
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๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ผ๐ป๐๐๐น๐๐ถ๐ป๐ด ๐ข๐๐๐๐ผ๐๐ฟ๐ฐ๐ถ๐ป๐ด ๐ฆ๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐ ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐ฎ๐ฌ๐ฎ๐ฐ-๐ฎ๐ฌ๐ฏ๐ฎ: ๐๐น๐ผ๐ฏ๐ฎ๐น ๐ฅ๐ฒ๐๐ฒ๐ฎ๐ฟ๐ฐ๐ต ๐ฅ๐ฒ๐ฝ๐ผ๐ฟ๐ Our report delves deep into the Regulatory Consulting Outsourcing Services Market, integrating both quantitative and qualitative data to provide comprehensive insights. Key areas explored include understanding the competitive landscape, identifying prominent providers of regulatory consulting services across various disciplines such as clinical, quality, and regulatory writing. Furthermore, we examine the factors driving market growth, including increasing complexity in clinical trials, stringent regulatory requirements, and the growing need for cost optimization. The report also delves into the diverse range of regulatory consulting services offered, encompassing regulatory strategy development, dossier preparation, and regulatory submissions management. By empowering stakeholders with valuable insights, our report facilitates faster market entry and informed decision-making. Additionally, it offers comprehensive company profiles of leading regulatory consulting service providers, detailing their service offerings and experience in specific therapeutic areas. Moreover, our market forecasts provide segment-wise growth calculations and projections for consumption value from 2024 to 2032. This data enables businesses to target specific and lucrative market niches for maximized returns. ๐ง๐ผ ๐๐ป๐ผ๐ ๐๐น๐ผ๐ฏ๐ฎ๐น ๐ฆ๐ฐ๐ผ๐ฝ๐ฒ ๐ฎ๐ป๐ฑ ๐๐ฒ๐บ๐ฎ๐ป๐ฑ ๐ผ๐ณ ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ผ๐ป๐๐๐น๐๐ถ๐ป๐ด ๐ฆ๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐. ๐ฅ๐ฒ๐พ๐๐ฒ๐๐ ๐ฎ ๐ฆ๐ฎ๐บ๐ฝ๐น๐ฒ ๐ฃ๐๐: https://lnkd.in/dZfFyrZG ๐ก ๐๐ ๐ง๐๐ฝ๐ฒ: Our report explores different types of regulatory consulting services, categorized by focus area (clinical research regulations, quality systems compliance, regulatory writing & submissions). โ๏ธ ๐๐ ๐๐ฝ๐ฝ๐น๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป: We analyze the utilization of regulatory consulting services across various stages of drug and medical device development, from pre-clinical studies to post-market surveillance. *๐๐ ๐ฅ๐ฒ๐ด๐ถ๐ผ๐ป: North America, Europe, Asia-Pacific, South America, Middle East & Africa ๐ข ๐๐ ๐๐ฒ๐ ๐ฃ๐น๐ฎ๐๐ฒ๐ฟ๐: IQVIA, PAREXEL International (India) Private Ltd , Syneos Health, Charles River Laboratories, ICON plc, WuXi AppTec., Eurofins Scientific Finland Oy #regulatoryconsultingservices #regulatoryaffairs #clinicalresearch #medicaldevices #pharmaceuticals #drugdevelopment #medicaltechnology #healthcareinnovation #compliance #outsourcing #marketresearch #marketanalysis #CRO #lifesciences
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๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ผ๐ป๐๐๐น๐๐ถ๐ป๐ด ๐ข๐๐๐๐ผ๐๐ฟ๐ฐ๐ถ๐ป๐ด ๐ฆ๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐ ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐ฎ๐ฌ๐ฎ๐ฐ-๐ฎ๐ฌ๐ฏ๐ฎ: ๐๐น๐ผ๐ฏ๐ฎ๐น ๐ฅ๐ฒ๐๐ฒ๐ฎ๐ฟ๐ฐ๐ต ๐ฅ๐ฒ๐ฝ๐ผ๐ฟ๐ Our report delves deep into the Regulatory Consulting Outsourcing Services Market, integrating both quantitative and qualitative data to provide comprehensive insights. Key areas explored include understanding the competitive landscape, identifying prominent providers of regulatory consulting services across various disciplines such as clinical, quality, and regulatory writing. Furthermore, we examine the factors driving market growth, including increasing complexity in clinical trials, stringent regulatory requirements, and the growing need for cost optimization. The report also delves into the diverse range of regulatory consulting services offered, encompassing regulatory strategy development, dossier preparation, and regulatory submissions management. By empowering stakeholders with valuable insights, our report facilitates faster market entry and informed decision-making. Additionally, it offers comprehensive company profiles of leading regulatory consulting service providers, detailing their service offerings and experience in specific therapeutic areas. Moreover, our market forecasts provide segment-wise growth calculations and projections for consumption value from 2024 to 2032. This data enables businesses to target specific and lucrative market niches for maximized returns. ๐ง๐ผ ๐๐ป๐ผ๐ ๐๐น๐ผ๐ฏ๐ฎ๐น ๐ฆ๐ฐ๐ผ๐ฝ๐ฒ ๐ฎ๐ป๐ฑ ๐๐ฒ๐บ๐ฎ๐ป๐ฑ ๐ผ๐ณ ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ผ๐ป๐๐๐น๐๐ถ๐ป๐ด ๐ฆ๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐. ๐ฅ๐ฒ๐พ๐๐ฒ๐๐ ๐ฎ ๐ฆ๐ฎ๐บ๐ฝ๐น๐ฒ ๐ฃ๐๐: https://lnkd.in/dZfFyrZG ๐ก ๐๐ ๐ง๐๐ฝ๐ฒ: Our report explores different types of regulatory consulting services, categorized by focus area (clinical research regulations, quality systems compliance, regulatory writing & submissions). โ๏ธ ๐๐ ๐๐ฝ๐ฝ๐น๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป: We analyze the utilization of regulatory consulting services across various stages of drug and medical device development, from pre-clinical studies to post-market surveillance. *๐๐ ๐ฅ๐ฒ๐ด๐ถ๐ผ๐ป: North America, Europe, Asia-Pacific, South America, Middle East & Africa ๐ข ๐๐ ๐๐ฒ๐ ๐ฃ๐น๐ฎ๐๐ฒ๐ฟ๐: IQVIA, PAREXEL International (India) Private Ltd , Syneos Health, Charles River Laboratories, ICON plc, WuXi AppTec., Eurofins Scientific Finland Oy #regulatoryconsultingservices #regulatoryaffairs #clinicalresearch #medicaldevices #pharmaceuticals #drugdevelopment #medicaltechnology #healthcareinnovation #compliance #outsourcing #marketresearch #marketanalysis #CRO #lifesciences
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Expert Insights: Navigating Complexities of Early Phase Clinical Trials ๐ข Shoutout to the team at Boyds for sharing insights on launching early phase clinical trials in their article: "Top 10 tips on how to start an early phase clinical trial" ๐ One standout point emphasises engagement with regulators early on. This proactive approach streamlines the process and opens doors to advice and incentives, setting the foundation for the trial's success. ๐ค Robust vendor management is pivotal in during setup and throughout. Collaboration and communication with service providers ensures alignment of objectives, enhancing efficiency and data quality. This synergy is crucial, especially in the highly regulated and dynamic environment of early phase trials. ๐ Dive deeper into the full article here: https://lnkd.in/dxdwYZUF #clinicaltrials #phase1 #risk #quality #compliance #pharma #biotech
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๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ผ๐ป๐๐๐น๐๐ถ๐ป๐ด ๐ข๐๐๐๐ผ๐๐ฟ๐ฐ๐ถ๐ป๐ด ๐ฆ๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐ ๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐ฎ๐ฌ๐ฎ๐ฐ-๐ฎ๐ฌ๐ฏ๐ฎ: ๐๐น๐ผ๐ฏ๐ฎ๐น ๐ฅ๐ฒ๐๐ฒ๐ฎ๐ฟ๐ฐ๐ต ๐ฅ๐ฒ๐ฝ๐ผ๐ฟ๐ Our report delves deep into the Regulatory Consulting Outsourcing Services Market, integrating both quantitative and qualitative data to provide comprehensive insights. Key areas explored include understanding the competitive landscape, identifying prominent providers of regulatory consulting services across various disciplines such as clinical, quality, and regulatory writing. Furthermore, we examine the factors driving market growth, including increasing complexity in clinical trials, stringent regulatory requirements, and the growing need for cost optimization. The report also delves into the diverse range of regulatory consulting services offered, encompassing regulatory strategy development, dossier preparation, and regulatory submissions management. By empowering stakeholders with valuable insights, our report facilitates faster market entry and informed decision-making. Additionally, it offers comprehensive company profiles of leading regulatory consulting service providers, detailing their service offerings and experience in specific therapeutic areas. Moreover, our market forecasts provide segment-wise growth calculations and projections for consumption value from 2024 to 2032. This data enables businesses to target specific and lucrative market niches for maximized returns. ๐ง๐ผ ๐๐ป๐ผ๐ ๐๐น๐ผ๐ฏ๐ฎ๐น ๐ฆ๐ฐ๐ผ๐ฝ๐ฒ ๐ฎ๐ป๐ฑ ๐๐ฒ๐บ๐ฎ๐ป๐ฑ ๐ผ๐ณ ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐ผ๐ป๐๐๐น๐๐ถ๐ป๐ด ๐ฆ๐ฒ๐ฟ๐๐ถ๐ฐ๐ฒ๐. ๐ฅ๐ฒ๐พ๐๐ฒ๐๐ ๐ฎ ๐ฆ๐ฎ๐บ๐ฝ๐น๐ฒ ๐ฃ๐๐: https://lnkd.in/dZfFyrZG ๐ก ๐๐ ๐ง๐๐ฝ๐ฒ: Our report explores different types of regulatory consulting services, categorized by focus area (clinical research regulations, quality systems compliance, regulatory writing & submissions). โ๏ธ ๐๐ ๐๐ฝ๐ฝ๐น๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป: We analyze the utilization of regulatory consulting services across various stages of drug and medical device development, from pre-clinical studies to post-market surveillance. *๐๐ ๐ฅ๐ฒ๐ด๐ถ๐ผ๐ป: North America, Europe, Asia-Pacific, South America, Middle East & Africa ๐ข ๐๐ ๐๐ฒ๐ ๐ฃ๐น๐ฎ๐๐ฒ๐ฟ๐: IQVIA, PAREXEL International (India) Private Ltd , Syneos Health, Charles River Laboratories, ICON plc, WuXi AppTec., Eurofins Scientific Finland Oy #regulatoryconsultingservices #regulatoryaffairs #clinicalresearch #medicaldevices #pharmaceuticals #drugdevelopment #medicaltechnology #healthcareinnovation #compliance #outsourcing #marketresearch #marketanalysis #CRO #lifesciences
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๐๐๐ซ๐ฅ๐ฒ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐ง๐ฏ๐จ๐ฅ๐ฏ๐๐ฆ๐๐ง๐ญ: ๐๐ญ๐ซ๐๐ญ๐๐ ๐ฒ ๐๐ง๐ ๐๐ฉ๐ฉ๐ซ๐จ๐ฏ๐๐ฅ ๐ก Bringing a drug to market has several scientific, clinical, regulatory and market access challenges that if not strategized properly, early in development, impacts the ROI once the product reaches commercialisation. Integrating a regulatory strategy with market access, re-imbursement, aligned to a clearly defined TPP allows for precise planning on how to get therapies to patients effectively. ๐ ๐๐ฐ ๐ฉ๐จ๐ข๐ง๐ญ๐ฌ ๐'๐ฏ๐ ๐ญ๐๐ค๐๐ง ๐๐ซ๐จ๐ฆ ๐๐จ๐ง๐ฏ๐๐ซ๐ฌ๐๐ญ๐ข๐จ๐ง๐ฌ ๐ฐ๐ข๐ญ๐ก ๐ฆ๐ฒ ๐ง๐๐ญ๐ฐ๐จ๐ซ๐ค: ๐ ๐๐ฅ๐ข๐ ๐ง๐ฆ๐๐ง๐ญ ๐ข๐ฌ ๐ค๐๐ฒ: When regulatory and commercial strategies don't go hand-in-hand, programmes risk facing several hurdles through development and commercialisation. ๐ฏ ๐๐ญ๐๐ซ๐ญ ๐๐๐ซ๐ฅ๐ฒ: Integrated regulatory strategies start from proof of concept and revisited as the product gathers safety and efficacy data through development. Regulatory navigate discussions with the authorities through this crucial period, acting as a vital interface to gain a better understanding of how the product needs to be positioned to maximise ROI. ๐ค ๐๐๐ฅ๐๐ญ๐ข๐จ๐ง๐ฌ๐ก๐ข๐ฉ๐ฌ: Regulatory experts who have taken products out of clinical holds and reversed multiple FDA/EMA decisions, hold their personal relationships with personnel in office as a fundamental contributor to these remarkable turn arounds. Interested to hear whether this resonates with any of my network, and as always eager to continue learning so feel free to share your thoughts! #regulatoryaffairs #biotech #pharma #fraserdove
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๐ https://www.docqc.com ๐ Discover the Future of Clinical Trials! ๐ Our innovative FSP solutions are here to revolutionize your research process. From protocol design to regulatory compliance, we offer a suite of services designed to streamline every stage of your clinical trial. Our expert team is committed to accelerating drug development, enhancing patient outcomes, and advancing medical science. Embrace a tailored approach with significant budget savings. Let's bring new therapies to market, together. Explore how we can support your journey to innovation. Visit our site now! ๐ฌ๐ก #ClinicalTrials #InnovationInHealth #FSPSolutions #DrugDevelopment #MedicalScience #PatientOutcomes #HealthcareTechnology #ClinicalResearch #ProtocolDesign #TrialOperations #DataManagement #RegulatoryCompliance #PharmaIndustry #Biotech #HealthTech #ResearchAndDevelopment #FutureOfHealthcare #ClinicalInnovation #TherapyAdvancement #PartnerInScience
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Next week our Director of Business Development, Anders Horn, will be at #lsiusa24 to meet with med device innovators and discuss ways in which we can help expedite their product's path to market in the US. We would love to see you there! At Accorto, we specialize in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA-regulated product concepts to market and work with providers of FDA-regulated products and services to ensure they are operating in a compliant manner. Let us take the complexity out of regulatory compliance through our full turn-key solutions across all stages of the regulated product lifecycle, including: - Regulatory Strategy Advisory - Regulatory Application Development, Publishing, and Submission - cGMP Compliance - Post-Market Support - Clinical & Non-Clinical Study Management Whether this is your first time bringing a product to market in the US or are looking for ways to reduce cost and expedite the process for your next project, we invite you to schedule a meeting with us at LSI USA to discuss how Accorto can streamline your to-market process! #LSIUSA2024 #medtechindustry #medtechinnovation #healthcareinnovation
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๐ https://www.docqc.com ๐ Discover the Future of Clinical Trials! ๐ Our innovative FSP solutions are here to revolutionize your research process. From protocol design to regulatory compliance, we offer a suite of services designed to streamline every stage of your clinical trial. Our expert team is committed to accelerating drug development, enhancing patient outcomes, and advancing medical science. Embrace a tailored approach with significant budget savings. Let's bring new therapies to market, together. Explore how we can support your journey to innovation. Visit our site now! ๐ฌ๐ก #ClinicalTrials #InnovationInHealth #FSPSolutions #DrugDevelopment #MedicalScience #PatientOutcomes #HealthcareTechnology #ClinicalResearch #ProtocolDesign #TrialOperations #DataManagement #RegulatoryCompliance #PharmaIndustry #Biotech #HealthTech #ResearchAndDevelopment #FutureOfHealthcare #ClinicalInnovation #TherapyAdvancement #PartnerInScience
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From simplifying regulatory compliance to improving drug development, IDP's applications are changing the game, making work more productive and data-driven. Dive in to our latest blog and see how #IDP is elevating the industry's performance! Read more: https://ow.ly/qt1E50PGiWv #IntelligentDocumentProcessing #DocumentProcessing
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