The Complex Landscape of FDA Recalls and Targeted Medical Devices The recent FDA actions have brought attention to a critical issue in the medical device industry: the gap between recall classifications and the continued use of targeted devices. Despite being identified for recall, many of these devices remain in use, highlighting a complex challenge for manufacturers, healthcare providers, and regulatory bodies alike. The FDA’s approach to recalls aims to protect patients, but the persistence of these devices in the market raises questions about the effectiveness and transparency of the recall process. As we navigate this intricate landscape, it's crucial for stakeholders to stay informed and proactive in ensuring patient safety and regulatory compliance. This situation underscores the need for continuous dialogue and innovation in medical device safety and regulatory practices. It's a reminder that our work in the biotech and medtech fields is not just about innovation, but also about safeguarding the health and well-being of patients. https://lnkd.in/gjSuGZkh #FDA #MedicalDevices #PatientSafety #RegulatoryCompliance #Biotech #MedTech
Viltis
Biotechnology Research
San Diego, California 8,502 followers
Delivering expert consulting services to pharmaceutical, biotechnology, medical device, and diagnostics companies
About us
We are a consultancy dedicated to crafting personalized resource solutions exclusively for pharmaceutical, biotechnology, medical device, and diagnostics companies. Our core mission is to provide expert solutions to organizations grappling with resource challenges, all while making a meaningful impact on the lives of our consultants. Over the years, our consultants, operating under the Viltis banner, have consistently delivered innovative solutions to some of the industry's largest and most renowned enterprises.
- Website
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http://www.viltis.com
External link for Viltis
- Industry
- Biotechnology Research
- Company size
- 11-50 employees
- Headquarters
- San Diego, California
- Type
- Privately Held
- Founded
- 2020
- Specialties
- Life Sciences, Consulting, Recruiting, Scientific, Quality, Engineering, Clinical, Regulatory, Biologics, Medical Device, Pharmaceutical, and IVD
Locations
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Primary
424 15th St
3111
San Diego, California 92101, US
Employees at Viltis
Updates
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🔬 Harnessing the Power of Disorder in Protein Design In a groundbreaking development, scientists have devised a method to design disordered proteins with specific properties, a technique that could revolutionize the field of drug discovery and development. Unlike traditionally structured proteins, these "controlled chaos" proteins offer unique functionalities that can be tailored for targeted therapeutic applications. This innovation opens new avenues for creating more effective and adaptable treatments, particularly in areas like cancer and neurodegenerative diseases. The potential to engineer proteins with desired behaviors could mark a significant leap forward in precision medicine. Exciting times ahead for biotech and drug development! What are your thoughts on this novel approach? https://lnkd.in/gqccFhEu #Biotech #ProteinDesign #DrugDiscovery #Innovation #PrecisionMedicine #Healthcare
Controlled chaos: Method to design disordered proteins could open door to new therapies
fiercebiotech.com
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🌍 A Resurgence in European Biotech Venture Capital? Despite a mixed market, signs point to a potential revival of venture capital in the European biotech sector, according to a recent PitchBook report. 📈 Investors are beginning to recognize the unique opportunities in Europe, driven by innovation, strong research institutions, and an evolving regulatory landscape. As we navigate through these challenging times, it's crucial for biotech companies to stay agile, innovative, and prepared to seize new opportunities. For those in the industry, what trends are you seeing that could drive this potential revival? Let's discuss! 💬 https://lnkd.in/eiEA7W4e #Biotech #VentureCapital #Innovation #Investment #Europe #Healthcare
Despite mixed market, a venture capital revival could be coming in Europe: PitchBook
fiercebiotech.com
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🌟 Viltis: Navigating the Digital Transformation in Healthcare 🌟 With industry giants like Pfizer launching platforms to streamline healthcare access, the landscape is rapidly evolving. At Viltis, we’re committed to guiding biopharma companies through these changes with our deep expertise in clinical trials, regulatory affairs, and digital health innovations. Our tailored consulting services ensure that you stay ahead in this dynamic environment, delivering the precision and support needed to thrive. Partner with Viltis to shape the future of healthcare together! 💊🔬 https://lnkd.in/gZagZ_Fu #Biopharma #HealthcareInnovation #RegulatoryAffairs #Viltis
Pfizer Launches PfizerForAll™, a Digital Platform that Helps Simplify Access to Healthcare
businesswire.com
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Navigating Clinical Trials: Viltis Is Here to Support Every Step of the Way Bringing a new therapy to market is no small feat. The clinical trial process is intricate, requiring careful planning, rigorous execution, and compliance with stringent regulatory standards. At Viltis, we specialize in providing expert consulting support across all phases of clinical trials. From Phase 1 safety assessments to Phase 4 post-marketing surveillance, our team is equipped to assist biotech and pharmaceutical companies with the expertise needed to succeed. Whether you're looking for Clinical Trials Managers, Clinical Research Associates, or experts in Quality, Regulatory, Clinical, Engineering, and Scientific disciplines, Viltis has you covered. Here’s how we can help: 🔍 Phase 1: Safety & Dosage Our experts ensure your early-stage trials are designed to minimize risks and optimize outcomes. 📈 Phase 2: Efficacy & Side Effects We assist with study design, patient recruitment, and data analysis, helping you gather critical insights for Phase 3. ✅ Phase 3: Large-Scale Testing From site selection to regulatory submissions, we manage every detail to keep your trials on track. 🔬 Phase 4: Post-Marketing Surveillance We provide ongoing safety monitoring and long-term efficacy assessments, ensuring your product's success in the market. At Viltis, we're committed to helping you accelerate the clinical trial process, ensuring that innovative therapies reach patients faster. Let's connect to discuss how our tailored consulting services can support your clinical trials and beyond. #ClinicalTrials #Biotech #Pharmaceuticals #DrugDevelopment #RegulatoryAffairs #ClinicalResearch #Viltis
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🚀 Biopharma Venture Capital Reaches New Heights in Q2 2024 🚀 The biopharma industry is witnessing a resurgence in venture capital activity, with Q2 2024 marking the highest quarterly funding level since 2022. According to recent reports, $7.6 billion was raised across 107 rounds, a significant increase from the previous quarter. This surge is driven by renewed investor confidence and a steady IPO market, signaling a bright future for innovation in biopharma. At Viltis, we are excited to see this momentum, as it reflects the growing opportunities in drug development and innovation. With venture capital flowing into early-stage companies and AI-driven drug discovery leading the way, the landscape is ripe for groundbreaking advancements. We're here to support this growth with our expertise in Quality, Clinical, Regulatory, and Engineering services. Let's continue to push the boundaries of what's possible in biopharma! 💡 https://lnkd.in/gS3eKuFy #Biopharma #VentureCapital #DrugDiscovery #Innovation #Viltis
Biopharma VC Funding in Q2 Reaches Highest Quarterly Level Since 2022
biospace.com
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We're #hiring a new Home Based Technical Recruiter - Life Sciences in United States. Apply today or share this post with your network.
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Viltis reposted this
🚀 We're Hiring! 🚀 Are you a talented recruiter with a passion for finding top-notch talent? We're excited to announce an opportunity to join our team as a Home-Based Technical Recruiter! This is a fantastic chance to work remotely, harness your recruiting expertise, and connect with some of the brightest minds in the Biotech industry. If you have a knack for identifying and engaging with exceptional candidates, we'd love to hear from you! 🔹 Position: Technical Recruiter 🔹 Location: Remote / Home-Based 🔹 Type: Contract What You'll Do: - Source and screen candidates for technical roles across various Life Science industries. - Collaborate with hiring managers to understand specific job needs and requirements. - Build and maintain a strong pipeline of qualified candidates. What We're Looking For: - Proven experience as a Technical Recruiter, ideally in a remote capacity. - Strong knowledge of technical roles and industry trends. - Excellent communication and interpersonal skills. If you're ready to take on a new challenge and work with a dynamic team, apply today! #Hiring #RecruiterJobs #TechnicalRecruiter #RemoteWork #JobOpportunity #JoinOurTeam
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🔍 Navigating the Complexities of Clinical Trials with FDA's Latest Guidance The FDA recently issued critical updates that could reshape the landscape of clinical trials, particularly with the role of Data Monitoring Committees (DMCs). This new guidance emphasizes the importance of specialized training for DMC members and their crucial role in ensuring the safety and efficacy of investigational drugs. By enhancing DMC oversight, the FDA is reinforcing its commitment to patient safety and ethical clinical practices. For those involved in drug development, these updates are not just procedural—they're foundational to maintaining the highest standards in our industry. Read more about the FDA's latest guidance and its impact on clinical trials here: https://lnkd.in/eMqGMwxG #ClinicalTrials #FDA #Pharma #Biotech #DrugDevelopment #Viltis
Focus on Clinical Trials: FDA Issues New Guidance on Data Monitoring Committees, Charging for Investigational Drugs, and Informed Consent | Insights | Ropes & Gray LLP
ropesgray.com
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🔍 Massachusetts' New Pay Range Transparency Law: A Game Changer for Biopharma? The introduction of Massachusetts' pay range transparency law marks a significant shift in the biopharma industry. This new regulation not only promotes fairness and equity but also strengthens the industry's appeal to top talent. At Viltis, we recognize the importance of transparency in fostering a culture of trust and inclusivity. By openly sharing pay ranges, companies can build stronger relationships with their employees, leading to higher retention rates and enhanced productivity. Moreover, this law could serve as a competitive advantage, attracting skilled professionals who value transparency and fairness. As the biopharma industry continues to evolve, it's crucial for companies to adapt to these changes and embrace transparency as a core value. We're excited to see how this new law will shape the future of our industry and are committed to supporting our partners in navigating this new landscape. https://lnkd.in/gyeDQwTh #Biopharma #PayTransparency #Viltis #WorkplaceEquity #Massachusetts #TalentAttraction #Leadership
Pay Range Transparency: New Law Could Help Massachusetts Biopharma Industry
biospace.com