ADRES Int'l Biotech Consultation & Execution

𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭 𝐮𝐩𝐝𝐚𝐭𝐞! FDA has just released the final guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations 𝐏𝐫𝐞𝐬𝐬 𝐭𝐡𝐞 𝐟𝐨𝐥𝐥𝐨𝐰𝐢𝐧𝐠 𝐥𝐢𝐧𝐤 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞. https://lnkd.in/gUs56N6W 𝐀𝐫𝐞 𝐲𝐨𝐮 𝐬𝐭𝐫𝐮𝐠𝐠𝐥𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐤𝐞𝐞𝐩𝐢𝐧𝐠 𝐩𝐚𝐜𝐞? We are here to help you align with the latest guidelines. 𝐂𝐨𝐧𝐭𝐚𝐜𝐭 𝐮𝐬 𝐡𝐞𝐫𝐞: https://lnkd.in/d_8jYVxw hashtag #pharma hashtag #Biotech hashtag #Biopharma hashtag #regulatoryaffairs hashtag #regulatorycomplience

𝐉𝐨𝐢𝐧 𝐮𝐬 𝐟𝐨𝐫 𝐚 𝐬𝐞𝐫𝐢𝐞𝐬 𝐨𝐟 𝐟𝐨𝐮𝐫 45-𝐦𝐢𝐧𝐮𝐭𝐞 𝐰𝐞𝐛𝐢𝐧𝐚𝐫𝐬 𝐨𝐧 𝐭𝐡𝐞 𝐛𝐚𝐬𝐢𝐜𝐬 𝐨𝐟 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐢𝐧 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭. If you are a startup developing a new medicinal product, whether you are still at the R&D or already in the clinical stages, you and your subcontractors are constantly generating data that will become your primary asset when you wish to go through a regulatory submission or if you want to reach out to investors. Handling the data according to #DataIntegrity (DI) principles and guidelines assures you that the data will be accepted and stay safe for the required duration. This introductory webinar will teach regulators' basic demands and expectations regarding DI. Speaker: Roy Zaibel, ADRES Co-CEO and Data Integrity Specialist Consultant Audience: QA directors, CEOs, COOs, CTOs, CMOs, Worldwide *This is the first in a series of four webinars on the topic of DI and computerized systems validation* The topics for the following webinars: - The 21cfr part 11 mystery - compatible but not compliant - Risks and Mitigations – Handling DI as an ongoing process rather than a one-time activity - Source Data Verification – a case study 𝐖𝐞 𝐨𝐟𝐟𝐞𝐫 𝐩𝐚𝐫𝐭𝐢𝐜𝐢𝐩𝐚𝐧𝐭𝐬 𝐚 𝐅𝐑𝐄𝐄 𝐜𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐞 𝐨𝐟 𝐭𝐫𝐚𝐢𝐧𝐢𝐧𝐠 𝐟𝐨𝐫 𝐭𝐡𝐞𝐢𝐫 𝐚𝐧𝐧𝐮𝐚𝐥 𝐃𝐈 𝐭𝐫𝐚𝐢𝐧𝐢𝐧𝐠 𝐚𝐟𝐭𝐞𝐫 𝐚𝐭𝐭𝐞𝐧𝐝𝐢𝐧𝐠 𝐚𝐥𝐥 𝐟𝐨𝐮𝐫 𝐰𝐞𝐛𝐢𝐧𝐚𝐫𝐬. #biopharma #regulatoryaffairs #pharmaceuticals #pharma #biotech #biotechstartups

𝐃𝐎 𝐘𝐎𝐔 𝐑𝐄𝐀𝐋𝐋𝐘 𝐍𝐄𝐄𝐃 𝐀 𝐔𝐒-𝐁𝐀𝐒𝐄𝐃 𝐂𝐎𝐍𝐒𝐔𝐋𝐓𝐀𝐍𝐂𝐘 𝐓𝐎 𝐁𝐑𝐄𝐀𝐊 𝐈𝐍𝐓𝐎 𝐓𝐇𝐄 𝐔𝐒 𝐌𝐀𝐑𝐊𝐄𝐓? 𝐓𝐇𝐈𝐍𝐊 𝐀𝐆𝐀𝐈𝐍! We are thrilled to announce a new strategic collaboration between ADRES, Kinexum Services LLC, and Dream Big Health—uniting the best of European innovation with the extensive expertise of US-based consultancy, offering a unique blend of local and international services.   𝐖𝐡𝐲 𝐂𝐡𝐨𝐨𝐬𝐞 𝐔𝐬?   With this collaboration, your company can now access:   ** 𝐔𝐒 𝐑𝐞𝐩𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 ** Benefit from a strong presence in the US market. ** 𝐌𝐚𝐫𝐤𝐞𝐭 𝐀𝐜𝐜𝐞𝐬𝐬 & 𝐑𝐞𝐢𝐦𝐛𝐮𝐫𝐬𝐞𝐦𝐞𝐧𝐭 ** Seamlessly enter and navigate the US market with guidance from experts who understand the landscape.   ** 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞 ** Gain invaluable insights into US regulatory processes, ensuring your product meets all necessary standards.   **𝐆𝐥𝐨𝐛𝐚𝐥 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐀𝐥𝐢𝐠𝐧𝐦𝐞𝐧𝐭 ** Align your US development strategy with your European and Rest of World (RoW) goals. ** 𝐱𝐅𝐃𝐀 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐚𝐧𝐭 𝐍𝐞𝐭𝐰𝐨𝐫𝐤 ** Tap into the vast professional network of our US-based consultants who bring years of experience from the FDA.   ** 𝐄𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧 ** Enjoy real-time communication, conducted in your time zone.   ** 𝐂𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐢𝐯𝐞 𝐏𝐫𝐢𝐜𝐢𝐧𝐠 ** Benefit from competitive pricing structures while accessing world-class services.   ** 𝐓𝐚𝐢𝐥𝐨𝐫𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 ** Receive customized services that are precisely aligned with your business requirements.   𝐎𝐏𝐄𝐑𝐀𝐓𝐈𝐍𝐆 𝐈𝐍 𝐓𝐇𝐄 𝐔𝐒𝐀 𝐂𝐀𝐍 𝐁𝐄 𝐄𝐀𝐒𝐘 & 𝐀𝐅𝐅𝐎𝐑𝐃𝐀𝐁𝐋𝐄!    By choosing us, you’re accessing world-class consultancy services, locally. Our local team will be at the forefront of your project, delivering the expertise you need with the cultural understanding and real-time communication that only a local partner can provide. We will strategically leverage Kinexum’s and DREAMBIG Health's US-based resources when required, ensuring that you receive the most efficient, cost-effective, and customized solutions. This approach ensures that you get precisely what you need, without any unnecessary costs, at the highest standard available.   We invite you to explore how this collaboration can accelerate your journey to success in the US and beyond. Let’s build the future of healthcare together.   𝘞𝘢𝘳𝘮 𝘳𝘦𝘨𝘢𝘳𝘥𝘴, Roy Zaibel Co-CEO at ADRES.bio roy@adres.bio #biopharma #pharmaceuticals #startups #regulatoryaffairs #biotech Darron Segall, MHS Thomas Seoh

#ShanahTova #Bringthemhome #StopWar

🌟 Unlocking New Hope for Rare Disease Treatments 🌟 Navigating the complexities of orphan designation is crucial for advancing treatments in the rare disease space. In our latest article, Liron Gibbs-Bar Ph.D. shares valuable insights into the process and benefits of securing this designation, offering guidance for biotech innovators and regulatory professionals. From fast-tracked approvals to extended market exclusivity, orphan designation is more than just a regulatory label—it's a pathway to making a profound impact. 🚀 #OrphanDrugs #Biotech #Biopharma #RareDiseases #RegulatoryAffairs #Innovation

In a compelling new article, Rivka Zaibel, President and Founder of ADRES Int'l Biotech Consultation & Execution, shares her personal reflections on nearly three decades of working with the European Medicines Agency (EMA). From attending a pivotal 1995 conference in Paris, where the EMA's creation was first announced, to witnessing its gradual transformation, Rivka offers unique insights into the agency's impact on regulatory affairs across Europe. Read Rivka's journey through the evolving landscape of European regulations! 👇 #Biotech #RegulatoryAffairs #EMA #HealthcareInnovation #ADRES

🌍𝐓𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞 𝐈𝐬𝐬𝐮𝐞 🚀 We’re excited to unveil the second issue of the Bio-Startup Standard, focusing on the unique challenges and opportunities for bio-startups in Europe. This edition dives deep into the dynamic landscape of innovation, regulation, and growth across the continent, offering valuable insights for entrepreneurs navigating the European biotech ecosystem. 𝘌𝘹𝘱𝘭𝘰𝘳𝘦 𝘵𝘩𝘦 𝘧𝘶𝘭𝘭 𝘪𝘴𝘴𝘶𝘦 𝘩𝘦𝘳𝘦: https://lnkd.in/dRaUVyqF #Biotech #Biopharma #Innovation #BioStartups #Europe #Entrepreneurship

In her latest article, Michal Zilberberg explores how the EU's tech transfer initiatives are revolutionizing the #pharmaceuticalindustry. With 25% of #pharmastartups born from these efforts, EU funding like the €2.5 million EIC Transition grants are game-changers. Discover how the EU's €95.5 billion Horizon Europe budget is driving groundbreaking innovation. Pharma startups like #Anaviri are already reaping the benefits, pushing the boundaries of #healthcare. Don't miss how these partnerships are shaping the future of medicine. Read the full Article! #biotech #biopharma #pharma

In the rapidly evolving landscape of US healthcare, early market access planning is crucial for the successful commercialization of innovations. In his insightful article, Darron Segall, MHS, co-founder of Dream Big Health, explores the essential strategies and considerations for navigating market access, from reimbursement pathways to value proposition. This guide is a must-read for innovators aiming to maximize their chances of successful market entry and adoption in the competitive US market. #biotech #biopharma #innovation #healthtech #Medtech #regulatoryaffairs