Checkliste zum Ausfüllen von IND- und BLA-Anträgen Deutschland

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  Maximize efficiency and minimize errors with our easy-to-use IND and BLA filling checklist.

  Our checklist GMP Anti-PD-1PD-L1 VHH provides you with a step by step roadmap that leads from your initial preparation to submitting the application and beyond. Throughout, we sprinkle in tips and advice to make your filing as seamless as possible.

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  Navigate the complicated world of IND and BLA filing with confidence using this powerful checklist.

  You must not miss any of the vital steps in the IND and BLA process, it is crucial. The filing of an IND or BLA is a highly detailed and precise process. Which is why it is a good idea to always refer back to our checklist GMP Anti-MMRCD206 VHH and ensure you tick ALL of the boxes.

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  Don't overlook any critical steps in the IND and BLA process u2013 use this checklist as your guide.

  Our checklist includes all the requirements as per the IND / BLA filing✅ This way, you can know that your application is comprehensive, factually correct and compliant with all of the FDA regulatory requirements.

Why choose Yaohai IND and BLA Filling Checklist?

• Qualitätssystem und Einhaltung globaler Vorschriften

  Yaohai BioPharma, a top 10 IND and BLA Filling Checklist, combines regulatory affairs and quality control. We have a quality system that is compliant with current GMP standards and regulations around the globe. Our regulatory team has deep understanding of world-wide regulatory frameworks. This lets us accelerate biological launches. We ensure traceable production procedures with high-quality products as well as compliance with the regulations of the US FDA and EU EMA. Australia TGA and China NMPA is also fulfilled. Yaohai BioPharma successfully passed an in-person audit conducted by an accredited Qualified Person of the European Union (QP) to examine our GMP system and production facility. We have also passed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Anpassung, Effizienz und Kosteneffizienz

  Yaohai Bio-Pharma is experienced in the development of microbial-derived biologics. We offer customized RD as well as manufacturing solutions, while making sure that there are no risks. We have worked on diverse modalities such as subunit-based recombinant vaccines, IND and BLA Filling Checklist, cytokines, growth factors, single domain antibodies, enzymes, plasmid DNA, the mRNA, and other. We are experts in a variety of microorganisms, including yeast extracellular and intracellular secretion (yields up to 15g/L) as well as bacteria intracellular soluble and inclusion body (yields as high as 10g/L). We have also developed the BSL-2 fermentation platform to create bacteria-based vaccines. We have a track record of improving production processes, thereby increasing yields and decreasing costs. With a highly efficient technology team, we ensure timely and quality project delivery and bring your products to market faster.

• Fachkompetenz und langjährige Erfahrung

  Yaohai Bio-Pharma is a leading Microbial biologics CDMO. We have been focused on microbial-produced therapeutics and vaccines for human, veterinary, and the management of pet health. We are equipped with IND and BLA Filling Checklist RD platforms as well as manufacturing technology that encompass the entire process beginning with the development of microbial strains cells, methods and processes, to commercial and clinical manufacturing which ensures successful implementation of cutting-edge solutions. We have acquired a large amount of experience in bio processing of microbial cells. We have delivered over 200 global projects, and help our clients with navigating the laws from the US FDA, EU EMA, Australia TGA, and China NMPA. Our professional expertise and extensive experience allows us to quickly respond to market demands and provide tailored CDMO services.

• Robuste Lieferkette und Fertigungskapazitäten

  Yaohai Bio-Pharma is a Top 10 biological company that specializes in IND and BLA Filling Checklist. We have built a modern manufacturing facility with robust RD capabilities and modern manufacturing facilities. Five drug substance production lines complying with GMP standards for microbial fermentation and purification along with two fill and final lines for vials and cartridges as well as pre-filled needles are readily available. The available fermentation scales vary between 100L and 2000L. The filling volume ranges from 1ml up to 25ml. Syringes or cartridges that are pre-filled are filled with 3 to 3.5ml. Our production workshop that is cGMP-compliant ensures constant supply of clinical sample and commercial products. Our facility produces large molecules that are exported to all over the world.

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