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Struggling with the complexities of drug development? DSI is here to support you! Submit your questions about regulatory drug development here --> https://lnkd.in/gC4_rpY5. Once you submit your inquiry, our team of Subject Matter Experts (SMEs) will review and route it internally to provide you with expert advice and guidance shortly. Let DSI help you navigate the intricate drug development landscape with ease. #DrugDevelopment #RegulatoryAffairs #PharmaSupport #AskDSI #Pharmaceuticals #Biotech #RegulatoryGuidance

Explore our revamped web pages for Small Molecule #Pharmaceuticals and #BioPharmaceuticals and discover how Shimadzu can address your analytical requirements. Whether your challenges are reducing the time to deliver pre-clinical drug candidates or ensuring lot-to-lot quality while maintaining data integrity, we have technologies built for your success. https://lnkd.in/g4Ds9Mp3 #pharmaceuticalsciences #biopharma #analyticalinstruments #shimadzu

Are you confused about which documents need to be submitted to the FDA via email and which ones should go through the eCTD Gateway? 📄✉️ In today's Orphan Minute, Dr. Cote breaks down the submission process, detailing documents required to be submitted by email and documents required for submission through the eCTD Gateway. Best practices to ensure compliance and efficiency. Don't miss out! #FDA #eCTD #eCTDGateway #Pharmaceuticals #RegulatoryAffairs #Compliance #Biotech #Pharma #OrphanDrug #OrphanMinute #OnlyOrphansCote

How are public and non-public review documents being used for regulatory reliance?   The latest CIRS R&D Briefing focuses on a study that gathered the perceptions of companies and regulatory agencies on the use and importance of non-public documents (e.g. full assessment reports), and public documents (e.g. public assessment reports) during a reliance review. The study found that public documents were not usually the only source of information for reliance, and that non-public documents were key for evaluating sameness and understanding reference agency decision making. Various challenges were identified in relation to the use of review documentation for reliance, and potential solutions were suggested, such as to develop best practices for the content and evaluation of reference agency reports.   Download the R&D Briefing >> https://lnkd.in/erqAPNVy #RegulatoryScience #pharmaceuticals #RegulatoryAffairs #RegulatoryReliance #RiskBasedDecisions

🔔 Update Alert! The General Administration of Stability has announced exciting updates on the submission and evaluation mechanisms for stability studies. Starting from Sunday, 25/8/2024, new procedures will be in place. 📋 To access the updated application mechanisms and guidelines, visit the Egyptian Drug Authority website for details on the content of the stability studies file. 🔗 All updated application links can be found on the General Administration of Stability's unified link, effective from Sunday, 25/8/2024. Stay informed to streamline your submission process! 📢 In addition, mark your calendars for a workshop on Tuesday, 3/9/2024, where company representatives can engage with the latest updates and foster collaboration with pharmaceutical entities. Don't miss this opportunity to stay ahead in the industry! #Update #StabilityStudies #Pharmaceuticals #Collaboration #IndustryInsights

Best Practices for ANDAs & Controlled Correspondence Submissions! 📑 The Division of Filing Review shared key insights on the Abbreviated New Drug Application (ANDA) process, addressing: - Common Refuse-to-Receive (RTR) Deficiencies 💡 - Key considerations for stability data and bioequivalence studies 📊 - Guidance for Controlled Correspondence and submission strategies 📝 Don't miss this valuable presentation on enhancing your submissions and reducing delays! Access the full content here. ⬇️ FDA #GenericDrugs #ANDA #Pharmaceutical #RegulatoryAffairs

Our new guide is now available: Your New Drug’s Smooth Path to Success: A Robust & Integrated Regulatory Strategy, from Day One. https://lnkd.in/dQmi_FSq This guide explores how a well-crafted regulatory strategy, integrated from the start, can significantly improve the chances of a new drug reaching market and benefiting patients. Sandra Lourenço, our Director of Regulatory Affairs – discusses the key challenges of drug development and how to overcome these. This guide has been developed together with our recent #TOPRA featured webinar, which you can view via this LinkedIn post here https://lnkd.in/dpsm4PyY #pharmaceuticals #regulatory 

How does an Independent service provider ensure a focused, unbiased approach to stability studies that guarantees reliable and high-quality outcomes? Laboratory Manager, Beccy B. blog looks at how reliable stability study results are essential for maintaining product safety, quality and compliance. https://hubs.ly/Q030vWG-0 #pharmaceuticals #pharma #testing #stability