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800 products advanced. 350 trials run. 350 regulatory submissions handled. 20 breakthrough designations delivered. When you need to advance your #medicaldevice, It Takes Avania. https://ow.ly/aIN550QnZ55 #clinicaltrials #clinicalresearch
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📊 Navigating Clinical Trials and Regulatory Affairs 🏥 My expertise extends to translating a wide range of documents for clinical trials and regulatory affairs, including contracts, protocols, informed consents, and more. Let's ensure compliance and accuracy. #ClinicalTrialsTranslation #RegulatoryAffairs
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Cost savings and expedited timelines?! Take a quick look at one of the many things we do best:
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It is crucial that you are ready to submit all required data and materials at the right stages and in the right formats for your regulatory submission. Our Clinical & Regulatory team are your expert partners. We can provide holistic strategic support throughout your regulatory submission. This includes activities like regulatory strategy, medical writing, and electronic Common Technical Document (eCTD) publishing support. We can also review anything you have produced so you can fix any errors or unproven claims prior to submission. Ensuring you are comprehensive in your materials, packaging and claims will mean fewer obstacles during the regulatory process, resulting in potentially shorter times to market. Our publishing support can be tailored to your treatment and can prevent you falling for common mistakes. Find out more about our Clinical & Regulatory services: https://buff.ly/3YILeR4 #publishingsupport #clinicalandregulatory #ectd #fdaapproval #regulatory #emaapproval #pharmaregulation #pharma #newdrug #drugdevelopment #regulatorypublishing
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Dive deep into the world of Regulatory Affairs with our comprehensive training program! Join us for expert-led sessions, interactive workshops and real-world case studies. Don't miss this opportunity to enhance your skills and stay ahead in the dynamic regulatory landscape. Register now to secure your spot! https://lnkd.in/gd4gYTAS #RegulatoryAffairsTraining #RegulatoryAffairs #RegulatoryAffairsCourse #PharmaceuticalRegulatoryAffairs #DrugRegulatoryAffairsCourse #RegulatoryAffairsCoursesOnline #CourseinRegulatoryAffairs
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Leading organizations partner with us to: ✅ Expedite regulatory submissions ✅ Generate savings with specialised terminology databases ✅ Shorten overall timelines Discover the key benefits of our regulatory solutions here: https://bit.ly/47N5J2c #Regulatory #RegulatoryAffairs #Clinical
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Navigating the complex world of regulatory affairs can be challenging, but with Regulatory EDUH Solutions by your side, you'll have the expertise and tools needed to succeed. Whether it's clinical trials, regulatory submissions, or post-market surveillance, we provide comprehensive solutions tailored to your needs. Discover more about how we can support your regulatory journey. Click Here: https://lnkd.in/gKwvTfXH #RegulatorySolutions #ComplianceExperts #EDUH
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This is an interesting read from Parexel Compliance is obviously crucial throughout clinical development but what does a 'phase-appropriate' compliance strategy look like? "Throughout early clinical development, the focus is on clinical data and outcomes. What is lacking is the appreciation of the resources needed to establish compliance and so the evolution of quality systems from GLP/GCP to GMP can be neglected. This results in developers being unprepared for and unsuccessful in regulatory approval, and significant delays to commercialization." https://lnkd.in/eTkJAPmw
Regulatory Strategies
insights.parexel.com
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