Anil Nalluri’s Post

[#BIOPC2024]- 📢 Louis Deschanel from Rombio at the 9th edition of the #Bioproduction Congress (BIOPC) talks about Artificial Intelligence for operationnal excellence with ROMBIO @Mabdesign #BIOPC #BiologicsDevelopability #analyticalmethods #ProcessModeling #DigitalTwins #Quality #Regulatory #Bioproductioncongress #bioprocessing #innovation #BreakthroughInnovations #SustainableManufacturing

Feeling overwhelmed by the upcoming audits and reviews? Maintaining control over critical issues while keeping efficiency high is possible! QDraft empowers you to do just that. Connect with Aruna Theerthahalli, M.Pharm, Ph.D to learn how QDraft Services LLP can support your team. #clinicalresearch #bioanalytical #bioequivalence #qualityassurance #audits #efficiency

[#BIOPC2024]- 📢 Belma Alispahic from AnalysisMode at the 9th edition of the #Bioproduction Congress (BIOPC) talked about Future-Proofing with AI-Powered Bioprocess Development @Mabdesign #BIOPC #BiologicsDevelopability #analyticalmethods #ProcessModeling #DigitalTwins #Quality #Regulatory #Bioproductioncongress #bioprocessing #innovation #BreakthroughInnovations #SustainableManufacturing

#Didyounotice? The IMDRF released 2 important documents, namely: 📌 𝑵𝒐𝒏 𝘐𝘯-𝘝𝘪𝘵𝘳𝘰 𝘋𝘪𝘢𝘨𝘯𝘰𝘴𝘵𝘪𝘤 𝘋𝘦𝘷𝘪𝘤𝘦 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘚𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯 𝘛𝘢𝘣𝘭𝘦 𝘰𝘧 𝘊𝘰𝘯𝘵𝘦𝘯𝘵𝘴 (n𝘐𝘝𝘋 𝘛𝘰𝘊). https://lnkd.in/ehUyqE_p 📌𝘐𝘯-𝘝𝘪𝘵𝘳𝘰 𝘋𝘪𝘢𝘨𝘯𝘰𝘴𝘵𝘪𝘤 𝘋𝘦𝘷𝘪𝘤𝘦 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘚𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯 𝘛𝘢𝘣𝘭𝘦 𝘰𝘧 𝘊𝘰𝘯𝘵𝘦𝘯𝘵𝘴 (𝘐𝘝𝘋 𝘛𝘰𝘊). https://lnkd.in/e4wK8FFJ This is an important update that requires the attention of multiple stakeholders including regulators, manufacturers, 𝗮𝗻𝗱 #𝗵𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲𝗽𝗿𝗼𝗳𝗲𝘀𝘀𝗶𝗼𝗻𝗮𝗹𝘀 as it provides a standardised structure for regulatory submissions globally. Reach out to Evnia if you need assistance to develop and implement the regulatory strategy of your portfolio! #biotech #biotechnews #invitrodiagnostics #companiondiagnostics #medtechnews #medtech #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #EVNIA_AR #Evnia_UKPR

[#BIOPC2024]- 📢 Mourad FERHAT, Ph.D from ACROBiosystems at the 9th edition of the #Bioproduction Congress (BIOPC) talked about Scaling Up Biomanufacturing with high quality raw materials and dedicated solutions @Mabdesign #BIOPC #BiologicsDevelopability #analyticalmethods #ProcessModeling #DigitalTwins #Quality #Regulatory #Bioproductioncongress #bioprocessing #innovation #BreakthroughInnovations #SustainableManufacturing

Failure to adequately validate endotoxin testing can result in the release of unsafe products. Not only jeopardizing patient safety but also exposing the company to significant regulatory and legal risks. To ensure your patient safety stays top of mind, streamline your alternative method validation. With our Endosafe® Alternative Bacterial Endotoxin Test Method Validation and Implementation service, we offer a documentation package with reports and data for primary validation, reducing the burden of extensive validation work. Discover how our streamlined validation package can enhance your validation accuracy and efficiency. Visit our page for detailed insights and support: https://okt.to/jTfgCr #EndotoxinTesting #Sustainability #Biotechnology #QualityControl #rCR #LaboratoryEfficiency #CharlesRiverLabs #Trillium #Endosafe

Is your quality control team struggling with extensive manual validation processes? Traditional methods can be labor-intensive, time consuming, and often lead to delays. Our Endosafe® Alternative Bacterial Endotoxin Testing Method Validation and Implementation package includes several necessary validation aspects (accuracy, precision, ruggedness, and robustness), allowing companies to perform a smaller portion of the validation work specific to their products. Reduce manual labor, speed up validation, and improve overall efficiency with our comprehensive documentation package. Discover how we can help streamline your validation process: https://okt.to/BlGwbZ #EndotoxinTesting #Sustainability #Biotechnology #QualityControl #rCR #LaboratoryEfficiency #CharlesRiverLabs #Trillium #Endosafe

Delays in regulatory approval can be costly and time-consuming. Navigating the submission process is one of the many things we're good at. As your regulatory partner, we can overcome obstacles and fast-track your product to market. Get started here: https://ow.ly/VpL850TCtnT #regulatory #usmarket #drugdiscovery #biotech

While robust regulatory processes are essential for #antibiotic & diagnostic R&D, the complexity and cost of navigating submissions per country can limit timely product availability. Streamlining these processes and approaches is a priority to help ensure access to new products.