A note from Dr. Scott Bruder, founder and CEO of BCVG: “Looking back over 2024, I'm proud to share that we have enjoyed another year of remarkable progress, capping off a decade of sustained and reproducible double-digit growth. “This year, we brought in over 130 new projects from around the world, ranging from custom-written surveys for physicians, numerous FDA clearances / approvals, and execution of non-clinical studies to M&A due diligence, complex portfolio analyses, and sophisticated PMA / BLA preparation activities. “In some cases, we have resurrected programs from their "death bed” and turned them into flourishing success stories through creative problem solving and perseverance. “The BCVG team has never been stronger, yet we cannot rest on our most recent success stories. “In this next decade, we intend to grow BCVG by delighting even more Client Partners in these therapeutic verticals, and adding more clinical areas as the relevant technologies mature. “We are committed to becoming the consulting firm recognized as an international leader in shepherding these novel ideas through the product development process and onto the market.” How can we help you reach your goals in 2025? Connect with us! #ClientPartners #biotech #managementconsulting #FDA #IntegratedInsights
Bruder Consulting & Venture Group’s Post
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Don't forget to join us at this year's 12th Annual Outsourcing in Clinical Trials Southern California event at the prestigious Hyatt Regency La Jolla at Aventine, San Diego, USA, on 24th-25 September 2024! 🔥What’s New This Year? 📝Keynote by the FDA: We are thrilled to announce that the FDA will deliver a keynote address on Inspection Readiness. This is a unique opportunity to gain firsthand insights from regulatory experts. 👥Informative Sessions on Diversity in Clinical Trials: Explore the FDA’s policies and initiatives of diversity within clinical trials through a dedicated session designed to deepen your understanding and help you implement inclusive practices in your trials. 💡New and Exciting Sessions: Our agenda is packed with new informative sessions that cover the latest trends and challenges in clinical trial outsourcing. Whether you're interested in innovative technologies, regulatory updates, or best practices, there’s something for everyone. Register now using code HAMK: https://shorturl.at/N29Il #OCTSoCal #ClinicalTrials #healthcare #pharma
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Psephos’ Irfan Hassan is attending the UK Regulatory Science & Innovation Networks Programme: Collaborative Networking Event today in London. Innovate UK and Innovate UK Business Connect welcome Discovery Phase Regulatory Science & Innovation Networks to come together with stakeholders from all parts of Innovate UK, the Office for Life Sciences, Medicines and Healthcare products Regulatory Agency (MHRA), and the wider regulatory and policy landscape to share best practice and explore options for future collaboration. We wish you all a successful day and are looking forward to hearing about the potential collaborations. #medtech #medicaldevices #lifesciences #MHRA #regulatorycompliance
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Join our A-Team of regulatory experts at the upcoming #RAPSConvergence in Long Beach, CA next week. Don’t miss our panel presentation, with case examples, on "Optimizing Health Authority Interactions and Outcomes" by Joshua Taylor, PhD, RAC, Sheila Plant, PhD, MHS, RAC, and Nadine Bouchard. In the meantime, you can check out our related blog titled, "Pre-NDA, and Pre-BLA Meetings: Effective Strategies for Gaining Marketing Approval" (https://lnkd.in/gTnykQef). We understand the challenges faced by our clients and offer a tailored approach to regulatory and drug development consulting that sets us apart. Come visit booth #1021 to meet our regulatory thought leaders and the rest of our team: Tim Burrows, Nick Sanich, and Nick Boyce. Plan ahead and schedule a meeting with us: https://lnkd.in/gJFCsRAQ #Allucent #BringNewTherapiesToLight #RegulatoryAffairs #rapsconvergence #drugdevelopment
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Filing of Responses and Amendments to Health Authorities. Learn how Freyr successfully filed the responses and amendments to CDSCO, USFDA, and Health Canada under stringent timelines. Download the proven case. https://lnkd.in/gUpJdPW2 #Pharmaceuticals #Publishing #Submissions #CDSCO #HealthCanada #USFDA #Amendments #CaseStudy #FreyrSolutions
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Allucent is returning to the RAPS Convergence meeting to share our expertise on “Optimizing Health Authority Interactions and Outcomes”. My collegues that are speaking have a wide range of experiences sucessfully engaging regulatory authorities across the world. Please stop by their session and the Allucent booth to gain insights from them or request a virtual meeting - we are here to support you! #Allucent #BringNewTherapiesToLight #RegulatoryAffairs #rapsconvergence #drugdevelopment
Join our A-Team of regulatory experts at the upcoming #RAPSConvergence in Long Beach, CA next week. Don’t miss our panel presentation, with case examples, on "Optimizing Health Authority Interactions and Outcomes" by Joshua Taylor, PhD, RAC, Sheila Plant, PhD, MHS, RAC, and Nadine Bouchard. In the meantime, you can check out our related blog titled, "Pre-NDA, and Pre-BLA Meetings: Effective Strategies for Gaining Marketing Approval" (https://lnkd.in/gTnykQef). We understand the challenges faced by our clients and offer a tailored approach to regulatory and drug development consulting that sets us apart. Come visit booth #1021 to meet our regulatory thought leaders and the rest of our team: Tim Burrows, Nick Sanich, and Nick Boyce. Plan ahead and schedule a meeting with us: https://lnkd.in/gJFCsRAQ #Allucent #BringNewTherapiesToLight #RegulatoryAffairs #rapsconvergence #drugdevelopment
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MILE - Medical Information Leaders in Europe are delighted to be part of the collaboration with Datapharm and ROTE LISTE® to improve access to Scientific Response Documents (SRDs) to answer medical information questions from healthcare professionals. For more information on the initiative that MILE are focusing on, visit our website https://lnkd.in/eqJu7Xkw #SRD #medicalinformation #digitalhealth #pharma #medicalaffairs
Datapharm is excited to announce it is partnering with ROTE LISTE® and MILE - Medical Information Leaders in Europe to improve the accessibility of medicines information in Europe. These strategic partnerships are a huge step forward in improving the accessibility of vital medicines information for healthcare professionals and patients in Europe, including enhancing the migateway platform and providing SRDs (Scientific Response Documents) in Germany. Read the full news release to learn more: https://hubs.li/Q02ZMDGw0 #Pharma #partnerships #MedicalInformation #GlobalHealthcare #medicinesinformation
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Filing of Responses and Amendments to Health Authorities. Learn how Freyr successfully filed the responses and amendments to CDSCO, USFDA, and Health Canada under stringent timelines. Download the proven case. https://lnkd.in/gUpJdPW2 #Pharmaceuticals #Publishing #Submissions #CDSCO #HealthCanada #USFDA #Amendments #CaseStudy
Read the Case Study
freyrsolutions.com
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Let us show you how to leverage your clinical outcome assessment (COA) strategy for multiple stakeholders. Discover the true value of your COA data for new treatments beyond labelling by joining our interactive ISPOR virtual short course: ‘Leveraging clinical outcome assessment (COA) data to maximise the value of new treatments beyond labelling’. This online course, led by COA experts, will run between 11am and 1pm EDT on 26 and 27 June — complete with interactive conversations about the power of your COA data. Will you be joining us? #ISPOR #pharma #healthcare
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Datapharm is excited to announce it is partnering with ROTE LISTE® and MILE - Medical Information Leaders in Europe to improve the accessibility of medicines information in Europe. These strategic partnerships are a huge step forward in improving the accessibility of vital medicines information for healthcare professionals and patients in Europe, including enhancing the migateway platform and providing SRDs (Scientific Response Documents) in Germany. Read the full news release to learn more: https://hubs.li/Q02ZMDGw0 #Pharma #partnerships #MedicalInformation #GlobalHealthcare #medicinesinformation
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CMS has until September 1 to announce the #MFP for negotiated drugs in IPAY 2026, but manufacturers of competitor products should be thinking through their response strategy now. The #IRA requires coverage on all #PartD plan formularies, which will impact contracting dynamics for 2026. Connect with Milena Sullivan, Megan West (Olsen), or another #AvalereExpert today to learn more: https://lnkd.in/eZiys9me #InflationReductionAct #DrugPricing #Medicare #healthpolicy
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