Batavia Biosciences’ Post

Every minute counts in bringing groundbreaking treatments from concept to clinic. Join us on June 18, 2024 as Florian Bächle, our Head of Operations Products & Manufacturing Services, leads a crucial discussion on streamlining early-stage drug development. 🔗 Register for the webinar: https://lnkd.in/eQTvMud6 What you will learn: ✔️Mitigate risks: learn about typical pitfalls most developers should avoid ✔️Timelines: gain insights on bottlenecks, and set up clear milestones ✔️Maximize efficiency: consulting with experts to bridge the compliance knowledge ✔️Cost-Effective Solutions: Explore alternative GMP manufacturing options that fit smaller budgets. #Solvias #PharmaDevelopment #DrugDevelopment #Webinar #Biotech #GMP

📢 Important Update: Revised Schedule M in India! 📢 Attention all pharmaceutical professionals! The revised Schedule M has been released, bringing significant changes to our regulatory landscape. This update is crucial for ensuring compliance and maintaining the highest standards in drug manufacturing and quality control. https://lnkd.in/gN4sQTDt

How exciting it is to discuss with biotech about their innovative projects and how proud they trust PLG to help them achieve a successful development!

#BioAirEvents - A fantastic and successful webinar was produced recently by BioAir and presented by Nature Research Custom Media. The webinar showed 𝗵𝗼𝘄 𝗹𝗮𝗯 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝘃𝗶𝘁𝘆 𝗰𝗮𝗻 𝗯𝗲 𝗱𝗿𝗮𝗺𝗮𝘁𝗶𝗰𝗮𝗹𝗹𝘆 𝗶𝗺𝗽𝗿𝗼𝘃𝗲𝗱, 𝗲𝗻𝗮𝗯𝗹𝗶𝗻𝗴 𝗮 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗿𝗲𝘁𝗵𝗶𝗻𝗸 𝗼𝗳 𝗹𝗮𝗯 𝗳𝗮𝗰𝗶𝗹𝗶𝘁𝗶𝗲𝘀 and showing 𝗵𝗼𝘄 𝗮 𝘄𝗲𝗹𝗹-𝘁𝗿𝗮𝗶𝗻𝗲𝗱 𝘄𝗼𝗿𝗸𝗳𝗼𝗿𝗰𝗲 𝗶𝘀 𝗰𝗿𝘂𝗰𝗶𝗮𝗹 𝗶𝗻 𝗱𝗿𝗶𝘃𝗶𝗻𝗴 𝘁𝗵𝗲 𝗳𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗔𝗧𝗠𝗣𝘀, including compliance with regulatory authorities. Weren't you able to follow it? Did you already have other commitments? It does not matter; we can help you! If you would like to watch it, click on the following link: 👇 https://lnkd.in/dTW-tPAZ #ATMP #Pharma #LabProductivity

Is Planning the Key to Success? 🔬💊 A well-crafted Product Development Plan (PDP) is the compass guiding successful drug development. Learn the secrets to creating an effective PDP with insights from Batavia Biosciences' CEO, Menzo Havenga. Discover how to plan correctly, expose challenges, involve experts, and join our webinar for deeper insights! 💡💼 ✅ Here: https://lnkd.in/eF8t64nV #StrategicPlanning #PharmaIndustry #ProductDevelopment #DrugDevelopment #Webinar #BataviaBiosciences #SuccessTips #CenterOfExcellence #CDMO #vaccineDevelopment #VaccineProduction

🎧 Join us on "Pharma - The last word" as Philip Katz and Komal Karnik Nigam dive into the latest FDA regulatory flexibilities for #drugapprovals. Discover how the FDA's evolving approach impacts #pharma and #biotech companies.   🔍 Five key takeaways: 1️⃣ Regulatory flexibility: FDA now accepts a single, well-controlled trial with confirmatory evidence, moving away from the traditional two-trial requirement. 2️⃣ Guidance evolution: Recent FDA guidance focuses on diverse forms of confirmatory evidence, reducing the burden of large, multicenter trials. 3️⃣ Natural history studies: Use of untreated patient data to establish external controls, enhancing trial comparisons. 4️⃣ Mechanistic evidence: Emphasis on understanding the biological pathway to justify clinical trial outcomes. 5️⃣ Strategic planning: Early consideration of data presentation and strategic regulatory interactions is crucial for successful drug approval.   🔗 Listen to the full episode, links are in the comments!   #Pharma #Biotech #FDA #RegulatoryAffairs #DrugApproval #Podcast

Exploring strategic options for Europe 🇪🇺 with your #orphandrug? Reach out to Eva Cruz de Castro to meet in San Sebatian 🇪🇸 at the upcoming Bio€quity organised by BioCentury Inc. to explore a partnership with Avanzanite Bioscience. Avanzanite acquires, licenses or distributes market-ready medicines for #rarediseases and commercialises them everywhere in Europe, even where nobody else will - so that NOONE'S LEFT BEHIND. If that resonates, email: [email protected] You should particularly meet Eva Cruz de Castro if you face challenges in Europe 🇪🇺. Perhaps, there are very few patients that could use your medicine. Or the market access issues are overwhelming. Or simply, you only have a bandwith to go to to 2–3 countries at launch. Whatever is the trouble, we love challenges. Our confidence is not superficial. We have an unrivalled track record in market access and market development. And we will make sure that all back-end operations are running smoothly - distribution, pharmacovigilance, medical information, quality, compliance etc. And when needed we will step in a bit earlier to tie things up together - with regulatory submission, some outstanding CMC work, patent prosecution etc.

I am looking forward to watching this webinar from Florian Bächle on streamlining drug development.

It's not long until Altasciences hosts a free symposium on Campus covering 'How to Safely and Effectively Accelerate Your Drug Development'. A panel of industry experts will discuss strategies to plan for successful drug development, including selecting the right regulatory pathway for safely securing market access faster. Secure your space here - https://ow.ly/KKZV50PzR9b #lifescience #drugdevelopment #regulatoryaffairs

Are you exploring options for #GMPpurification in Kg scale? Look no further! Ardena, your trusted CDMO partner, specializes in large-scale #PreparativeHPLC and can support your needs as soon as tomorrow, ensuring the highest #quality and compliance with GMP standards. With Ardena, you can count on a seamless and efficient downstream purification process. Contact us now at [email protected] for more information. To learn more about our expertise in large-scale GMP purification, don't miss out on our exclusive resources on drug purification: 🔸 Watch our webinar: https://lnkd.in/diazMaVp 🔸 Dive deeper with our comprehensive whitepaper: https://lnkd.in/dtrgbUab At Ardena, we're dedicated to accelerating your drug development journey and bringing molecules to the clinics and to the market. Trust in our expertise, and let's navigate the path to success together. #Ardena #CDMO #DrugPurification #GMP #DownstreamProcessing