MMS’ Post

When approaching a regulatory submission to the FDA, EMA, or other global health authorities, you need the right data-focused clinical research organization that will consistently produce cohesive, quality-focused, and scientifically accurate documents. This is MMS. Click the link below 👇 to read case studies, review whitepapers, and learn why sponsors say, 'From day one, we were impressed with the efficient and smart decisions brought forth by MMS to bring this drug to market.' More: https://hubs.li/Q02qg0TC0 Leave a comment on how you feel working with or for MMS!💬 #OneMMS #pharma #drugdevelopment

Our #ClinicalDecisionSupport and drug referential tools expand students’ #medicaleducation to better prepare them for clinical and #pharmacy practice. Watch the video to learn more: https://ow.ly/KHhE50PkApV #medicalstudent

Our #ClinicalDecisionSupport and drug referential tools expand students’ #medicaleducation to better prepare them for clinical and #pharmacy practice. Watch the video to learn more: https://ow.ly/K40Y50Pk4bV #medicalstudent

𝐓𝐨𝐩 𝐑𝐞𝐚𝐬𝐨𝐧𝐬 𝐟𝐨𝐫 𝐅𝐃𝐀 𝐑𝐞𝐣𝐞𝐜𝐭𝐢𝐨𝐧 𝐢𝐧 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧 ▶️ https://lnkd.in/e_6RnfYH Contact BIOBOSTON CONSULTING today or visit our  website to learn more about how we can support your organization. #pharmaceuticals #biotechnology #medicaldevices #consulting #fda  #quality #compliance #qualityassurance #regulatoryaffairs

Our #ClinicalDecisionSupport and drug referential tools expand students’ #medicaleducation to better prepare them for clinical and #pharmacy practice. Watch the video to learn more: https://ow.ly/K40Y50Pk4bV #medicalstudent

“While a patient or prescriber may believe that a drug is safe or effective because of individual experience, such subjective experiences can be misleading and insufficient to establish safety and effectiveness. Instead, FDA relies on carefully designed clinical trials that weigh the risks and benefits of taking a drug compared with the risks and benefits of taking placebo or another accepted therapy. Carefully designed clinical trials have repeatedly demonstrated that the safety and effectiveness of drugs cannot be adequately established from anecdotal evidence or consumer or prescriber preferences." - Janet Woodcock, MD FDA Principal Deputy Commissioner #pharmacy #pharmacybenefits #PBM #employeebenefits #humanresources #compliance

📘 Week 2 in the REGBOOK [COMPLIANCE] Series: Illuminating the Regulatory Nexus 🔍 Dive deeper into the regulatory cosmos with #REGBOOK Week 2! 🚀 This week, we unravel the intricate threads that bind Good Clinical Practices (GCPs) to three pivotal aspects, shedding light on the dynamic relationships that govern our pharmaceutical landscape. 🌐 Explore the nuanced connection between Bioavailability and Bioequivalence requirements with GCPs, as we navigate the crucial terrain where efficacy meets ethical standards. 🧪 Venture into the labyrinth of premarket approval for medical devices (21 CFR Part 814), where GCPs act as guiding beacons ensuring the safety and efficacy of cutting-edge technologies. 🩺 Lastly, join us in unraveling the symbiotic relationship between Investigational New Drug Application (21 CFR Part 312) and GCP, a nexus crucial for the seamless progression of groundbreaking therapies from conception to clinical reality. 🌟 It's not just about regulations; it's about understanding the intricate dance between compliance and innovation. Let's illuminate the regulatory nexus together! 💼💡 #REGBOOK #ClinicalTrials #GCPCompliance #RegulatoryInsights #InnovationInHealthcare

🌟 Exploring the significance of Clinical Trial Protocols in Drug Development: Discover why these documents are the backbone of successful trials, why it is mandated by the US FDA, and how they drive quality data.📜  Click the link to learn more about Clinical Trial Protocolos: https://lnkd.in/ddE8PGhK     #adiintellect #clinical #trial #protocol #importance #components #challenges #clinicalstudy #clinicalprotocols #regulatoryguidelines

Join my friend Paula Garcia Calavia as we host our first regulatory webinar of the year! She will delve into key strategies for navigating the IND application process seamlessly. Don’t miss out on insights into optimizing IND submissions and fostering smoother communication with the FDA no matter where you might be in the world. Secure your spot today! #RegulatorySuccess #ClinicalTrials #IND #Webinar #FDAInsights

The spread of false information online can be a major hurdle for pharmaceutical and biotechnology companies trying to share accurate information with patients about their products and the conditions they treat. A new draft guidance shared yesterday by the US FDA offers a roadmap for these companies to effectively combat misinformation – placing a focus on the use of #socialmedia. The draft offers several examples of tailored responses to false or misleading statements that comply with the FDA’s regulations, along with a few examples of when these regulations may apply.   In a time where navigating the digital landscape is more complicated than ever, well-planned #communications strategies can help with establishing targeted responses that address specific false claims, building trust with science-backed messaging, and utilizing trusted social media platforms to ensure patients have access to accurate information about their health.   #Pharma #Healthcare #Misinformation #DiseaseAwareness