HiRO - Harvest Integrated Research Organization’s Post

Watch our on-demand webinar in collaboration with TOPRA - The Organisation for Professionals in Regulatory Affairs: Integrated Pharma Regulatory Strategy as the Key to Market Advantage. Are you struggling with a fragmented regulatory approach that’s slowing down your innovative therapies? Click here for the full recording of the session and access to the slides. https://lnkd.in/eJ8_frHF . This webinar will equip you with the power of an integrated pharma regulatory strategy. Our experts will reveal how to: * Unify your regulatory efforts for a streamlined path to market. * Minimize risks and navigate complex frameworks with confidence. * Shave valuable time off your development timeline. Our team are also available to take any questions or help. Kate Coleman - VP Regulatory, Quality & Compliance (Principal Consultant) Jayne Hunt - Principal Consultant, Regulatory Sam Tomlinson - Vice President, Global Drug Safety Sandra Lourenço - Director of Regulatory Affairs Or simply contact us at solutions@arriello.com . #pharma #biotech #regulatory #pharmaceuticals

🚀Master IND Applications: Your Ultimate Guide🚀 Navigating the complexities of Investigational New Drug (IND) applications can be challenging. Our latest guide simplifies the essential components, submission process, and labeling requirements to streamline your IND application and ensure success. 🔍 Key Highlights: Administrative Module: -Form FDA 1571 -Form FDA 1572 Submission Process: - Electronic submission - Common Technical Document (CTD) format Labeling Requirements: - Caution Statement - Drug Identification - Storage Conditions Packaging Guidelines: - Proper container closure systems - Tamper-evident packaging 📥Download PDF: Comprehensive Guide to IND Applications If you find any discrepancies, please let us know. 📢 Stay Informed: Follow us for more updates on drug development and regulatory affairs. #ClinicalResearch #DrugDevelopment #INDApplication FDA #pharma #regulatoryintelligence #eu RAPS Europe #regulatoryexcellence #Pharmaceuticals #Biotech #kaust #university #RegulatoryAffairs #usfda #HealthcareInnovation #research ♻️ Repost if you found this helpful!

Transform Your Global Regulatory Strategy with Alexavi Innovative Regulatory Consulting At Alexavi Innovative Regulatory Consulting, we understand the hurdles and complexities of navigating the regulatory landscape, especially in the dynamic fields of biotech and pharmaceuticals. Our seasoned experts are equipped to propel your projects forward, ensuring compliance and timely market access. Why Choose Alexavi? Expertise: Our team comprises industry veterans with decades of experience in FDA and EMA regulatory pathways. Customization: We tailor our strategies to meet your unique needs, adapting to the nuances of your product and target markets. Speed to Market: With Alexavi, accelerate your product's journey from lab to market, reducing delays and maximizing ROI. 🌐 Whether you're launching a new drug, navigating complex regulatory requirements, or need strategic advice, Alexavi is your go-to partner. Let us handle the regulatory maze, so you can focus on innovation and product development. 🔗 Reach out today! Connect with us to explore how we can support your next project. Visit [Insert Website Link] or contact [Insert Contact Information]. #Pharmaceuticals #Biotech #RegulatoryAffairs #DrugDevelopment #Innovation #AlexaviConsulting #MedicalDevice

🌐 Thank you to our Platinum Level Sponsor, Global Compliance Partners 🚀 Global Compliance Partners are setting new standards in compliance and regulatory solutions. Their expert team is dedicated to ensuring that innovations in healthcare meet the highest standards of safety and efficacy. 🧪With a deep understanding of the complex regulatory landscape, Global Compliance Partners provide comprehensive guidance and support to organizations navigating these challenging sectors. Their expertise spans from clinical development to market, ensuring that products not only comply with regulations but also excel in quality. #GlobalCompliancePartners #lifesciences #biotech #pharmaceuticals #complianceexcellence #RegulatoryInnovation 🌍💊

💡 Industry Insight: Small Pharma Drug safety leaders speak - Key challenges to address pharmacovigilance needs. Find out what PV leaders from across the industry had to say, including: ▶ The 4 key challenges for PV organizations ▶ Practical solutions to support PV teams ▶ Actionable steps to optimize PV in line with global regulatory requirements. 👉 Read the full white paper here: https://lnkd.in/dnYdYj4X 📢 Join the Qinecsa PV Insights Network https://lnkd.in/dhKgA9Vk Qinecsa brings together best-in-class technology and scientific expertise to connect life science companies to the right safety solutions. #Pharmacovigilance #DrugSafety #SmallPharma #Biotech #QinecsaPVInsightsNetwork #PVCommunity

🎤 “𝐂𝐞𝐥𝐞𝐠𝐞𝐧𝐜𝐞 𝐥𝐞𝐚𝐝𝐬 𝐢𝐧 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐢𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞, 𝐡𝐞𝐥𝐩𝐢𝐧𝐠 𝐜𝐥𝐢𝐞𝐧𝐭𝐬 𝐦𝐚𝐤𝐞 𝐢𝐧𝐟𝐨𝐫𝐦𝐞𝐝 𝐝𝐞𝐜𝐢𝐬𝐢𝐨𝐧𝐬 𝐟𝐨𝐫 𝐭𝐡𝐞𝐢𝐫 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐩𝐨𝐫𝐭𝐟𝐨𝐥𝐢𝐨𝐬.” Hear from Lakshmeenarayana Goundalkar (LGG), our Chief Delivery Officer of Regulatory Services, as he shares how Celegence’s expertise delivers reliable, fast, and high ROI regulatory services through the seamless integration of people, process, and technology. 𝐖𝐡𝐲 𝐂𝐡𝐨𝐨𝐬𝐞 𝐂𝐞𝐥𝐞𝐠𝐞𝐧𝐜𝐞? ▶𝐆𝐥𝐨𝐛𝐚𝐥 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: Tap into our global pool of subject matter experts across multiple therapeutic areas.  ▶𝐌𝐚𝐫𝐤𝐞𝐭 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠: Gain from our advanced understanding of local markets and a robust partner ecosystem.  ▶𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬: Benefit from our strategic advantage in providing recommendations that support compliance and accelerate time to market. 🌟 Ensure global product availability with Celegence’s regulatory intelligence services. Need expert regulatory support? Get in touch with Celegence today: https://lnkd.in/g9bGxh6U #RegulatoryIntelligence #LifeSciences #Pharmaceuticals #MedicalDevices #Celegence #GlobalRegulations #Compliance #MarketAccess 

⚙️ Mastering Adaptability: Thriving in Regulatory Affairs Amidst Industry Shifts ⚙️ The biotech, medical device and pharmaceutical sectors are known for their rapid transformations. As Regulatory Affairs professionals, ability to adapt is paramount. Share your experiences navigating changes in regulations, technologies, and market dynamics?  #AdaptabilityInRegulation #CareerResilience

𝗔𝗙𝗗𝗢-𝗥𝗔𝗣𝗦 𝗛𝗲𝗮𝗹𝘁𝗵 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝘃𝗲 𝘾𝙤𝙢𝙗𝙞𝙣𝙖𝙩𝙞𝙤𝙣 𝙋𝙧𝙤𝙙𝙪𝙘𝙩𝙨 2024  𝙊𝙘𝙩𝙤𝙗𝙚𝙧 9𝙩𝙝 – 10𝙩𝙝 𝙞𝙣 𝙋𝙧𝙤𝙫𝙞𝙙𝙚𝙣𝙘𝙚, 𝙍𝙄 Since 2015, the #CombinationProductsSummit has united the healthcare products industry to work for a better tomorrow. The community continues to be led by top regulatory officials and worldwide industry leaders who built the framework for the regulatory landscape of combination products. Join us to drive innovation and navigate the complexities specific to the world of combination products, resulting in the delivery of safe, effective, and high-quality products to the patients who need them.  Register here: https://lnkd.in/e_bYMyPq AFDO/RAPS Healthcare Products Collaborative Regulatory Affairs Professionals Society (RAPS) #mdr #ivdr #medicaldevices #diagnostics #CDx #pharmaceuticals #regulatoryaffairs #combinationproducts

Watch our TOPRA - The Organisation for Professionals in Regulatory Affairs sponsored webinar: Integrated Pharma Regulatory Strategy as the Key to Market Advantage. Are you struggling with a fragmented regulatory approach that’s slowing down your innovative therapies? This webinar will equip you with the power of an Integrated Pharma Regulatory Strategy. Our experts will reveal how to: * Unify your regulatory efforts for a streamlined path to market. * Minimize risks and navigate complex frameworks with confidence. * Shave valuable time off your development timeline. Click here for the full recording and access to the slides. https://lnkd.in/eJ8_frHF Kate Coleman Jayne Hunt Sam Tomlinson Sandra Lourenço Erik Smit #pharma #regulatory #quality