BioProcess International的动态

Contract development and manufacturing organizations (CDMOs) offer expertise in areas such as drug formulation, analytical testing, regulatory affairs, and quality control that help pharmaceutical clients bring products to the market more efficiently and cost effectively. For drug development projects ranging from small-scale clinical trials to large-scale commercial manufacturing, a CDMO can help solve key challenges including: ·?Cost Management: Assist in managing costs by leveraging their proficiency and economies of scale to optimize processes and reduce waste. ·?Capacity Constraints: Providing the capacity needed to meet demand for pharmaceutical companies that may not have the internal capacity to manufacture products at scale. ·?Regulatory Compliance: Ensure that their client’s products meet a range of requirements related to quality, safety, and efficacy by providing guidance in regulatory compliance and quality control. ·?Technology & Innovation:?Supply access to innovative technologies and knowledge in the latest trends and innovations in drug development and manufacturing within the constantly evolving pharmaceutical industry. ·?Time to Market: Accelerate product deployment by leveraging their experience and equipment to optimize processes and?streamline development, manufacturing, and approval timelines. With complete?medication packaging solutions?for liquid cup packaging tailored to the unique needs of a CDMO, MPI systems promote the highest level of efficiency, compliance, and traceability throughout the manufacturing and administration process. #cdmo #costmanagement #regulatorycompliance #qualitycontrol #speedtomarket

On 18th August 2023, I had the privilege of attending a highly informative webinar on the "Development of Injectable Unit and Manufacturing Process", organized by Shri Gajanan Maharaj Shikshan Prasarak Mandal’s Sharadchandra Pawar College of Pharmacy. The session provided valuable insights into the latest advancements in injectable drug manufacturing, including technical aspects, regulatory considerations, and industry best practices. This opportunity allowed me to deepen my knowledge and stay abreast of current trends in pharmaceutical manufacturing. I am grateful for the opportunity to learn from distinguished experts and to engage with fellow professionals in the field. Looking forward to applying the knowledge gained in my ongoing professional development. #PharmaceuticalIndustry #InjectableManufacturing #PharmacyEducation #RegulatoryAffairs #Webinar #PharmaceuticalDevelopment

Is GMP Required for Early Cell Line Development? Discover expert insights from Margit Holzer, Ph.D., on this critical question! Join us for the 2nd edition of the Masterclass: "Introduction to Phase-Appropriate Regulatory & Compliance Expectations for CMC of Biopharmaceuticals" with the renowned Margit Holzer, scheduled for December 11-12, 2024. ?? Key Takeaways: ?? Comprehensive review of ICH guidelines and FDA/EMA process validation ?? Tailored CMC content for each clinical development phase ?? Practical insights from real-world case studies on data integrity ?? Unique networking opportunities with leading industry professionals This masterclass is a must-attend for professionals in Regulatory Affairs, Quality Assurance, and CMC Project Management aiming to stay ahead in the ever-changing biopharmaceutical industry. ?? Secure your spot now: https://lnkd.in/d_QFXyDk ?? For inquiries: [email protected] ?? Contact us: +1 657 452 8174 Don't miss out—reserve your place today! #Biopharmaceuticals #RegulatoryAffairs #QualityAssurance #CMC #PharmaTraining #PharmaIndustry #Celllinedevelopment

Regulatory and manufacturing alignment is not just advantageous, it’s non-negotiable. Join our expert-led webinar to dive into the essential roles of regulatory affairs, process development, and manufacturing in driving successful microbial biopharmaceutical commercialization. ?? Date: Thursday, 21 November ? Time: 11 am EST | 8 am PST | 5 pm CET ?? Register here: https://lnkd.in/ex-MN8z7 In this session, you’ll gain insights into: ? Effective integration of regulatory affairs with process development ? Methods to streamline manufacturing while upholding quality standards ? Strategies for accelerating commercialization timelines Ideal for professionals in regulatory, manufacturing, and process development who are committed to maintaining robust drug quality throughout the commercialization process. #Biopharma #Webinar #DrugDevelopment #Bioprocessing #QualityAssurance #LonzaBio

Elevate your regulatory drug development journey with Enkrisi! Our innovative hybrid model combines traditional regulatory CMC strategy with the latest technology for unmatched efficiency. Experience how Augmented Intelligence and data analytics can simplify the regulatory process for you. Join us at the forefront of drug approvals, where every challenge becomes an opportunity for success. Let's reshape the future together. Explore more here! Enkrisi #Enkrisi

Excited to dive into the world of pharmaceuticals! From lab experiments to commercial production, every step is crucial. Join me as we explore API development, process scaling, and regulatory affairs. Let's unravel the complexities together! https://bit.ly/3wOVuxL #PharmaJourney #APIDevelopment #RegulatoryAffairs

???????????????? ?????? ?????? ?????????????? ???????????????????? ?????????????? ?????? ???????????? ?????????????????????????? ?? When working on complex projects like implementing a new Regulatory Information Management System (#RIMS), communication between different teams can make or break the outcome. For a top 10 generics pharmaceutical company, we played a crucial role as the linking pin between their Regulatory Affairs business team and the vendor’s configuration specialists. Our role was clear: We ensured that business requirements were translated into technical configurations. We aligned project activities across teams to meet the challenging timelines. We developed solutions for configuration and migration challenges as they came up. By serving as the go-between, we helped the project stay on track, ensuring a system configuration that met the client’s specific regulatory needs without unnecessary complexity. ?? Want to learn more about this project? Check out the full case study here: https://lnkd.in/er-FNxwY #RegulatoryAffairs #LifeSciences #Pharmaceuticals #ProgramManagement

Another to the List , Completed Drug Commercialization Course Authorized by University of California San Diego. Equipped with invaluable knowledge on regulatory affairs, market analysis, and product launch strategies. Ready to apply learnings to drive innovation in the pharmaceutical industry. #DrugCommercialization #MarketAnalysis #DrugLaunch #RegulatoryAffairs #ProductCommercializationStrategy #PharmaBusiness

Proud to have been part of this amazing project! Collaborating with both the Regulatory Affairs team and the configuration specialists was a challenging yet rewarding experience. It was great to see how we came together to translate business requirements into a system that not only meets regulatory needs but also streamlines processes for the client. The teamwork and problem-solving throughout the configuration and migration phases truly made the difference. Looking forward to more projects like this! ?? #Teamwork #RegulatoryAffairs #SystemConfiguration #LifeSciences #ProgramManagement

What We Do Best At NEXUS Regulatory Solutions, our name says it all—we provide comprehensive regulatory solutions for companies in need. Why Choose NEXUS? Our team of experts brings a wealth of experience across a broad spectrum of regulatory needs. We specialize in pharmaceutical products, medical devices, combination products, and even cultured meat. Our expertise extends to plasma products, biological products, lyophilized products, and sterile products, each governed by a myriad of regulatory guidance documents. We boast real-world product submission experience across multiple regions including the US, EU, UK, Switzerland, Australia, Canada, Israel, Singapore, and beyond. Whether it’s new product approvals or post-approval changes, we handle everything from large-scale projects like new site qualifications and process qualifications to the smallest of modifications. This is the essence of "NEXUS." We connect all your regulatory needs seamlessly.