Syner-G BioPharma Group’s Post

Unlock the benefits of expert Regulatory CMC guidance for your early-phase studies. Our blog highlights how Syner-G BioPharma Group can help streamline development and reduce risks.

Excited to share feedback from a big Pharma client upon completion of analytical assignments! “I want to thank you for everything you have helped us in different capacities. There are many things that you have been a great example for. Some of these are your ability to see the big picture and yet, treat every data set with utmost care and respect, your ability to see issues and risks and not be afraid to present these based on sound scientific reasoning. Without your critical thinking, broad view and support, we would not be where we are on the analytical sections!" The assignments included analytical gap assessments, authoring and review of 3.2.S and 3.2.P sections for NDA/MAA submission of an oral dosage form indicated for blood disorders. Can we help you with your needs in analytical and CMC development, authoring and review of CTD sections and CRO/CDMO management? Visit us at: https://lnkd.in/d77JKuFf A few specific examples of where DAT Pharma can help you include: •Lead analytical program, e.g., design analytical plan, review experimental design, protocols, results, troubleshooting, and reports •Impurities ID and controls for raw materials and finished products •Manufacturing: order of addition, analytical controls, technology transfer •Program management including selection and management of CROs/CDMOs •CMC: strategies, starting materials, write and review 3.2.S and 3.2.P sections for IND, IMPD NDA, MAA, 505(b)(2), ANDA, and PAS submissions, Help in responding to complete response letters •Veeva-Vault document management system: CTD content creation & reviews •Establish reference standard program (characterization, method validations, and qualification) including review of experimental design, protocols, results, and reports •Stability studies: Strategies and design •E&L method development and validations •Establish or remediate cleaning validations •Remediate analytical validation, compendial compliance, and transfer work •Help develop batch records and analytical controls for raw materials (drug substance and excipients) and drug products at in-process, release, and stability testing •Help in root-cause analysis of CAPA, OOS, and FAR •Write and review SOPs •…. #FDA, #emea, #NDA, #MAA, #analytical, #cmc, #CAPA, #OOS, #stability, #referencematerials, #impurity, #CRO, #CDMO

ICH Q12 Guideline for Better #Pharmaceutical Product Lifecycle Management! 🚀📊 Key Highlights: - Framework Enhancement: #ICHQ12 offers a comprehensive #framework to streamline the management of post-approval CMC #changes. 📈 - Efficiency: By leveraging ICH Q12 tools, applicants can significantly reduce the necessity for post-approval submissions. 🛠️ - Scientific Development: Stronger scientific development and #riskmanagement lead to more robust #lifecycle management. 🔍 - Quality Systems: Implementing #qualitysystems throughout the #productlifecycle increases efficiency and #compliance. 🏭

Reviewers and writers on our CMC team delivered high quality chemical and product development reports on time. To learn more, click here: https://bit.ly/cmcwriting #cmc #cmcwriting #ndafiling #fdaapproval #fda #regulatorycompliance #regulatory #regulatoryaffairs #drugsafety #pharmacovigilance #pharma #pharmaceuticals

Reviewers and writers on our CMC team delivered high quality chemical and product development reports on time. To learn more, click here: https://bit.ly/cmcwriting #cmc #cmcwriting #ndafiling #fdaapproval #fda #regulatorycompliance #regulatory #regulatoryaffairs #drugsafety #pharmacovigilance #pharma #pharmaceuticals

Imagine your pharmaceutical company has rolled out new software to manage drug manufacturing processes, confident in its validation. But was it thoroughly tested? 🤔 Computer System Validation (CSV) is essential to ensure that systems work as intended, meet regulatory standards, and deliver consistent quality. Without comprehensive CSV, issues can slip through, risking incorrect batch records, delayed product releases, and costly compliance breaches. 🚨 In our latest blog post, we dive into how combining scripted and unscripted testing ensures robust CSV for compliance, accuracy, and system reliability. 👇 https://hubs.li/Q02W04Tr0 #CSV #ComputerSystemValidation #Pharma

Imagine your pharmaceutical company has rolled out new software to manage drug manufacturing processes, confident in its validation. But was it thoroughly tested? 🤔 Computer System Validation (CSV) is essential to ensure that systems work as intended, meet regulatory standards, and deliver consistent quality. Without comprehensive CSV, issues can slip through, risking incorrect batch records, delayed product releases, and costly compliance breaches. 🚨 In our latest blog post, we dive into how combining scripted and unscripted testing ensures robust CSV for compliance, accuracy, and system reliability. 👇 https://lnkd.in/e98F6QFA #CSV #ComputerSystemValidation #Pharma

Reviewers and writers on our CMC team delivered high quality chemical and product development reports on time. To learn more, click here: https://bit.ly/cmcwriting #cmc #cmcwriting #ndafiling #fdaapproval #fda #regulatorycompliance #regulatory #regulatoryaffairs #drugsafety #pharmacovigilance #pharma #pharmaceuticals

📢 Commissioning, Qualification, and Validation (CQV): A Critical Component in Biotech Facilities In the biotech and pharmaceutical industries, meeting stringent quality and regulatory standards isn’t just a goal—it’s a necessity. CQV is the foundation that ensures systems and processes within these facilities operate at peak performance, safeguarding product quality and patient safety. Why is CQV so essential? 🌟 🔹 Regulatory Compliance: Proper CQV helps organizations adhere to regulatory frameworks like FDA, EMA, and other global standards, ensuring facilities and equipment consistently produce safe, effective products. 🔹 Operational Readiness: By verifying that systems are installed and operating as intended, CQV enables a seamless transition from setup to production, minimizing downtime and maximizing efficiency. 🔹 Product Quality: CQV ensures critical systems are qualified to maintain the highest product quality, giving patients the confidence to receive safe and reliable treatments. As biotech innovation accelerates, maintaining robust CQV processes becomes even more crucial for companies to stay compliant and uphold quality standards. 💼 Have you experienced the impact of CQV in your facility? Let’s discuss how these practices drive excellence in biotech! #CQV #Biotech #Pharma #QualityAssurance #RegulatoryCompliance

🚀 Navigating the CMC Roadmap to a Successful Phase 1 Clinical Trial 🚀 The journey from lab to clinic is a complex one. As we work to bring new treatments to patients, understanding the critical milestones in the CMC (Chemistry, Manufacturing, and Controls) process is key to success. This CMC roadmap for Phase 1 clinical trials illustrates the essential steps involved, from project kick-off to regulatory submissions and stability programs. Whether you're new to biopharma or an experienced CMC professional, this guide will help ensure that your process is on track to meet regulatory and quality standards. ⚙️ Key steps include: 1️⃣ Project Kick-off 2️⃣ Formulation Development 3️⃣ Process Development 4️⃣ Analytical Method Development... and much more! While the specifics can vary across organizations, this is a solid framework for understanding the overall journey. 🔍 Disclaimer: This roadmap is a generic guide, and minor details may vary depending on the organization, product, or regulatory requirements. 🔔 Follow me for insights into CMC project management and biopharma innovation you won't want to miss! ♻️ If you believe this post could benefit someone in your network, please hit repost. #LearnWithVikas #BlatthausBio #CMCProjectManagement #CMC #DrugDevelopment #Phase1Trial #ClinicalTrials #RegulatoryAffairs #InnovationInPharma