ISPE Singapore Affiliate’s Post

This tremendous session has been designed by the following parameter: ➡️Goals & Roles of Regulatory affairs professionals ➡️ Investigational New Drug (IND) application. ➡️ Generic drug product ➡️Drug Master File (DMF) ➡️Marketing Authorization Application ➡️ Common Technical Documents ➡️ Certificate of Suitability and many more to learn... You can obtain this course through the link below: https://lnkd.in/gchuBNxm #International_Regulatory_Affairs

As the complexity of drug-device combination products increases, so do the regulations surrounding them. Are you confident in your ability to appropriately explain your new device to regulators? This Drug Development & Delivery editorial from our Vice President, Regulatory Affairs, Nicholas Smalley, provides valuable tips for advocating for your products. https://lnkd.in/dmejdnVA #drugdiscovery #drugdevelopment #pMDI

FDA’s PQ/CMC Data Standards development effort is an iterative process. The eCTD sections identified in the table above are some of the sections that FDA is structuring in early iterations. There are plans to review and structure other sections within this Phase in the near future. PQ/CMC structuring and standardization is intended to be accomplished in multiple phases. For the first phase, the Agency has focused on some of the sections of ICH eCTD that will provide the foundation for future phases. Phase 1 covers the following topics: Drug Product, Drug Substance, Quality Specification, Batch Formula, Batch Analysis and Stability. Phase 2 data standards are under development, and will cover the following topics: Drug Product Manufacturing, Drug Substance Manufacturing, etc. #fda #fdaapproval #fdacompliance #regulatoryaffairs #regulatory #regulatorycompliance #CMC #regulatorysubmissions #drugs #regulatoryrequirements #Dossier #regulatoryupdate #regulatoryexcellence #regulatorystrategy #regulatoryreporting

FDA ADVICE ON CONSULTANCY CHOICE Carmelo Rosa, FDA Director of International Drug Quality, says it is obvious to the FDA when companies choose to work with a consultancy that provides a cookie cutter approach to regulatory enforcements. The FDA is tracking these types of responses across companies and sees the same language being used. This is not advisable. So word to the wise, choose a consultancy that provides you a strategy with effective and measurable responses specific to your company's needs.   Your company is unique and deserves to be treated like it is. Choose QxP. https://lnkd.in/esjSVG3d #pharma #biotech #qualityassurance #india

Three major announcements are coming! 🔔 ❗ In just one week, my team and I will be in #London for #AGBreakthrough where we'll share the latest developments in how ArisGlobal is transforming #lifesciences. (Hint: the announcements might be bigger than Big Ben 😉)

eCTD: Simplifying Drug Submission Worldwide The eCTD, or Electronic Common Technical Document, has become the primary method for submitting drug information for approval in numerous countries, such as the USA, Canada, Europe, Australia, and China. This standardized format streamlines the submission process, making it quicker and more organized. In the USA, the FDA provides guidance and tools like the Electronic Submissions Gateway for these submissions. Similarly, other countries have their own sets of guidelines and tools. Therefore, familiarity with eCTD and its implementation in various regions is essential for professionals involved in drug approval processes. To access further details or obtain the guidelines, please visit the official websites of the respective regulatory agencies. #eCTD #DrugApproval #pharma #regulatoryaffairs #pharmaceuticalindustry #regulatoryintelligence #eu #TGA #china #Healthcanada #USFDA

🌍 ND Global: Navigating Global Regulations 🌏 In the world of #MedicalDevice and #Pharmaceutical regulations, ND Global has your back! 🌐 🔍 We simplify the complex by offering: 📋 Regulatory Planning ✅ Compliance Assistance 📨 Submission Support From TGA (Australia) to ANVISA (Brazil), we've got you covered in 🇨🇦 CAN, 🇬🇧 UK, 🇸🇦 SA, 🇯🇵 JP, 🇦🇺 AU, 🇨🇳 CN, 🇧🇷 BR, and 🇨🇭 CH. 🗺️ Our mission: Craft a unified, efficient regulatory roadmap for you. One strategy to rule them all! 🚀 Click here to know more >> https://lnkd.in/dGdghBty #RegulatoryCompliance #GlobalRegulations #Healthcare #Efficiency #NDGlobal  

What is Premarket Notification 510(k)? Each person who wants to market in the U.S.,Class I, II, and III device intended for human use, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act. #marketing #quality #manufacturing #content #administration #administration #manufacturing, #pharmaindustry, #founders, #manufacturers, #pharmaceuticalindustry, #regulatory, #manufacturing, #ceomindset, #ceoinsights, #audits, #auditor, #compliancesolutions, #sops, #procedures,#laboratory, #dataintegrity, #documentation; #traininganddevelopment ; #trainingneeds; #trainingtips; #ceoagenda; #founderstory; #owners, #ownersrepresentative, #collegesanduniversities, #pharmacycollege, #bpharm, #pharmacy, #mpharm, #healthcareprofessionals #pharmacy #pharmacystudent. #medicaldevices #softwaredevelopment #software #fda

#EMA NEWS 🆕 A new version of the EMA pre-authorisation procedural advice for users of the #centralised #procedure has been released on July 2023. It includes some interesting reviews regarding different topics, but the most extensive review has been made in the #Data #exclusivity, #marketing #protection and marketing exclusivity section. In fact, two new questions have been included 6.1.4. When do the periods of data exclusivity/marketing protection start? 6.1.5. What is the period of protection for a PUMA? 6.1.6. What are the protection periods for orphan medicinal products? The centralised procedure will gain more relevance in the next years in the framework of the new Pharmceutical Regulation, so it is really important to understand how it needs to be addresed. This is a very useful document that provides an overview of the EMA’s position on issues, typically addressed during pre-submission meetings.  #pharma #biotech #regulation #compliance

Enkrisi's Reimagining Regulatory Pathways Services provide various services covering technical and strategic aspects of regulatory drug development. Let us help you set up an overall strategy that covers all potential risks while still meeting your objectives. #regulatoryaffairs #drugdevelopment #strategy https://hubs.ly/Q01Wf72y0