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We pride ourselves on cultivating a strong, broad, and deeply talented Partner network with countless years of experience... Though sometimes our clients need a little bit of help understanding how best to take advantage of that. That's why we introduced 'Products'. A 'product' is a service that one our Partners can provide, directly to the client, just as described. Products will be listed on a Partner's profile, along with their bio and case studies, so our clients can see how all our deeply experienced Partners can help their business. Introducing products will allow the next level of transparency between the phraktion Partner and the client, not only on service but price too. These products will be up on the website to explore soon! Global Medical Affairs powerhouse Arron Mungul offers a great example for how Products work. Whether you are working on a new strategy for a product in clinical development or you have already launched, it is critical to gain key medical insights throughout the lifecycle. And Arron does just that, putting together a functional advisory board that can evaluate new clinical data, understanding the treatment landscape, or gain insights into whether to begin clinical development in a new indication. All for a fair and transparent price. We know our Products will help us change the way work gets done in pharma, so see for yourself at phraktion.com And if you want to learn more about Arron’s product specifically, contact us at info@phraktion.com phraktion.com #product #pharma #fractional

We educate and we collaborate with organizations to ensure that you have the tools you need in order to succeed. The FDA appreciates early contact and opportunities to collaborate. We recommend that our Client Partners take advantage of this. We can work collaboratively to help evaluate the reimbursement landscape and implications of a device, drug or exempt designation before a company or creator forges ahead. Planning for the future helps ensure that your product has the right portfolio of clinical studies to publish in support of maximal payment as soon as possible after FDA approval. If you’re looking for someone with whom to collaborate, BCVG would be honored to join you and chart a path forward together. DM us or visit our website: bruderconsulting dot com. #ClientPartners #biotech #managementconsulting #tissueengineering #IntegratedInsights

With GLP-1s being used by more and more consumers, many see them as the closest thing #medicine has to a silver bullet for a host of costly diseases. With still so much uncertainty around the magnitude and breadth of the impact on existing medical drugs, devices, and procedures, leaders in the #healthcare and #lifesciences industries need to adapt their business strategies to win big in this new era for healthcare. Learn how: Authors: Betty Pio, Cian Wade ,and Fernando Perez-Hickman Escolar

🎤 Speaker Spotlight: Christine Cwieka🎤 We’re thrilled to highlight one of our speakers, Christine Cwieka, Human Factors Engineer at Design Science Group, LLC, for the Prefilled Syringes & Injection Devices 2024 event! 🌟 In this role, Christine collaborates with clients as their human factors expert to design and execute usability studies in accordance with Human Factors standards and guidance and meets the expectations of FDA and international ministries of health. Christine’s presentation will focus on how Human Factors engineering impacts the safe use of drug delivery systems, such as pre-filled syringes and injection devices. As more treatments shift to at-home care, patients and caregivers are taking on greater responsibility. Christine will explain the importance of minimizing user errors and ensuring drug delivery is effective. She’ll also emphasize the need to integrate Human Factors early in the development process to meet regulatory requirements and avoid issues later on. Join us in December! https://lnkd.in/e7T2MgSn 💥 #PrefilledSyringes2024 #InjectionDevices #PharmaceuticalInnovation #MedicalDevices #IndustryLeadership #DesignScience #PFS #PharmaEd

🔥 𝙒𝙖𝙣𝙩 𝙖 𝙎𝙞𝙜𝙣𝙚𝙙 𝘾𝙤𝙥𝙮 𝙤𝙛 𝙏𝙖𝙢𝙞𝙣𝙜 𝙩𝙝𝙚 𝘽𝙞𝙜 𝙋𝙝𝙖𝙧𝙢𝙖 𝙈𝙤𝙣𝙨𝙩𝙚𝙧? 𝙃𝙚𝙧𝙚’𝙨 𝙃𝙤𝙬 𝙩𝙤 𝙂𝙚𝙩 𝙔𝙤𝙪𝙧𝙨! Are you ready to learn how to "𝘁𝗮𝗺𝗲 𝘁𝗵𝗲 𝗺𝗼𝗻𝘀𝘁𝗲𝗿" that is the Regulatory CMC and Drug Development Supply Chain? Hedley Rees has exposed the hard truths about our industry in this eye-opening book — and we have signed copies to share with you! 👉 𝗪𝗮𝗻𝘁 𝗼𝗻𝗲? 𝗜𝗳 𝘆𝗼𝘂'𝗿𝗲 𝗮𝗰𝘁𝗶𝘃𝗲𝗹𝘆 𝘄𝗼𝗿𝗸𝗶𝗻𝗴 𝗼𝗻 𝗮 𝗗𝗿𝘂𝗴 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 𝗶𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗣𝗵𝗮𝘀𝗲 𝗧𝗿𝗶𝗮𝗹𝘀, 𝗛𝗲𝗿𝗲’𝘀 𝗵𝗼𝘄 𝘁𝗼 𝗴𝗲𝘁 𝗶𝘁: 1️⃣ Comment below and answer this question: 𝗪𝗵𝗮𝘁’𝘀 𝘁𝗵𝗲 𝗯𝗶𝗴𝗴𝗲𝘀𝘁 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝗮𝗻𝘆 𝗳𝗮𝗰𝗲𝘀 𝘄𝗶𝘁𝗵 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗠𝗖 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗮𝗻𝗱/𝗼𝗿 𝘀𝘂𝗽𝗽𝗹𝘆 𝗰𝗵𝗮𝗶𝗻? 2️⃣ Share this post with your network and tag colleagues here who may want to weigh in. We’ll DM you to arrange shipping. 𝗕𝘂𝘁 𝗵𝘂𝗿𝗿𝘆, 𝘄𝗲 𝗼𝗻𝗹𝘆 𝗵𝗮𝘃𝗲 𝗮 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 𝗻𝘂𝗺𝗯𝗲𝗿 𝗼𝗳 𝘀𝗶𝗴𝗻𝗲𝗱 𝗰𝗼𝗽𝗶𝗲𝘀 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲! Don’t miss this chance to add a rare, signed copy to your shelf. Let’s start the conversation — drop your answer below! 👇 And if you know someone else in the industry who would love this book, tag them in the comments! #pharma #biotech #CMC #regulatorycompliance #supplychain Hedley Rees Enkrisi FDA Madison Peterson

Is collaboration the key to success? Working collaboratively with FDA/EMA and adhering to published Guidance Documents is a smart strategy. Why? Because FDA appreciates early contact and opportunities to collaborate, and we recommend you take advantage of this. Evaluate the reimbursement landscape and implications of a device, drug or exempt designation before you forge ahead because planning for the future helps ensure that your product has the right portfolio of clinical studies to publish in support of maximal payment as soon as possible after FDA approval. Examine the market model, COGS, and margins for profitability well before investing in capital-intensive elements. If you are wondering what this means… reach out! BCVG can help. DM us for more information. #ClientPartners #biotech #managementconsulting #tissueengineering #IntegratedInsights

Navigating the complex world of life sciences, especially in combination products, is a journey filled with challenges and opportunities. These products, blending drugs, devices, and biological products, are more than just scientific marvels; they are the future of medical innovation. But the real question is, how do we efficiently and safely bring these products to market while adhering to FDA regulations? It's about understanding the intricate landscape of life sciences and finding solutions that work. From addressing regulatory complexities to integrating drug and device designs, each step is crucial. Join me in exploring ways to navigate these challenges, improve efficiency, and prioritize safety. Interested in a deeper dive? Check out my blog post for more insights: https://lnkd.in/gMWwCezt #lifesciences #medicaldevices #FDAregulation

Enhancing Regulatory Decision-Making: Utilizing Real-World Data from Electronic Health Records and Medical Claims for Drug and Biological Products. At Zyfis Lifesciences, we are committed to advancing clinical research through cutting-edge data analysis. We are pleased to share this PDF, sourced from RWD, for your information and professional insight. #zyfislifesciences #drug #Regulatory #clinicalresearch #dataanalysis #medical #clinicaltrial

https://lnkd.in/dM29mT7n ➡ Clinfinite Solutions is a global leader in clinical development solutions, offering end-to-end services with over 25 years of experience. ➡Our expertise spans preclinical and clinical domains, supporting trials of all phases and sizes worldwide. ➡Our teams, including supply chain specialists and regulatory compliance experts, seamlessly integrate into workflows, ensuring streamlined operations and efficient trial management. ➡We provide custom kitting, equipment, ancillary solutions, and biorepository services to meet diverse trial needs. ➡With a track record of supporting over 100 clinical trials, our quality, expertise, and convenience drive clinical research forward. ➡From regulatory consulting for BioPharma and MedTech companies to site management across all phases, we offer comprehensive solutions for successful trial outcomes. ➡Our medical writing services cover regulatory, clinical/device, safety, and scientific areas, delivering high-quality content to life sciences companies globally. ➡Trust Clinfinite Solutions for optimized clinical trials, supported by responsive, expert teams and tailored solutions to meet your needs, anywhere in the world. #ClinfiniteSolutions #ClinicalDevelopment #ClinicalTrials #MedicalWriting #RegulatoryConsulting #LifeSciences #BioPharma #MedTech #GlobalHealth #Healthcare #ClinicalResearch #TrialManagement #RegulatoryAffairs #Safety #ScientificWriting

PRE-ORDER NOW AVAILABLE: STATE OF THE STERILE FILL-FINISH MARKET 2024. The most comprehensive research assembled by Expert Insights on the Sterile Fill-Finish market with insights from the world’s leading experts and KOL’s in the Pharma Services industry. A must read report for investors, consultancies and companies in Pharma Services and Life Sciences. We answer the most challenging industry questions. What are the current capacities of outsourced manufacturers? What CDMOs are making the most investments to increase capacity and have the highest potential for growth? What companies are most likely to be investment targets for Private Equity and Big Pharma? Global CDMO Market Share and Capacity. Demand vs Capacity by Format. PFS Capacity for GLP-1s – Current and Future. Receive a 15% discount off Single or Corporate User Licenses for pre-orders August 8-30, 2024. Publication date September 1, 2024. Order Report Here: https://lnkd.in/eiTj_q8N For Inquires: clientservices@expertinsightsconsult.com Table of Contents: https://lnkd.in/eiTj_q8N Published by Expert Insights, The World's Leading Advisory Services, Investment Research and Strategy Consulting Firm in Pharma Services. #pharmaservices #PEInsights #privateequity #healthcareinvesting #pharmaservices #PE #privateequityfunds #bio #dcat #bioevents #cdmo #Cpo #Cpos #cro #clinicalresearch #contractpackaging #drugdevelopment #bio #contractmanufacturing #investing #healthcareindustry #cphi #cphiphila #investmentbankers #investmentbanking #mergersandacquisitions #venturecapital #vc #vcfundng #privateequityfirms #privatecredit #privatedebt #investorrelations #DealCloud #financialservices #hedgefund #familyoffice #familyoffices #corporatedevelopment #duediligence #dd https://lnkd.in/eiTj_q8N