CMC Regulatory Compliance for Pharma Deutschland

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  Navigating the Complex Regulatory Landscape of CMC Compliance in Pharma

  Yaohai has coached experts who understand the rules. These people are said to have studied of laws and has made sure that everything Yaohai does is acceptable with the law. And he says they collaborate with the central government to make sure Yaohai's medicine and Scale-up mikrobieller biopharmazeutischer Prozesse are up to code. It is a team effort to keep everyone safe. 

  
  

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  Streamlining CMC Regulatory Processes for Optimal Pharma Performance

  Yaohai is a team that ensure all things run softly. Every person has his job and potentially few will help. They work with the assistance of technology (think computers and machines) in either faster or more accurate fashion. This is how they can make medicine faster and get it to the people who need it. 

  
  

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  Herausforderungen und Lösungen

  Although Yaohai has quite some well performance CMC, they are struggling with certain challenges. That has been a single struggle to maintain with all the adjustments going on. Rules are constantly changing and the government is updating them every now & then which Yaohai must know about. If they overlook any new rule might affect the safety of their medicine. 

  
  

Why choose Yaohai CMC Regulatory Compliance for Pharma?

• 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 CMC Regulatory Compliance for Pharma 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.

• Qualitätssystem und Einhaltung globaler Vorschriften

  Yaohai BioPharma, a top 10 Microbial CDMO that integrates quality management and regulatory affairs. Our quality system that is compliant with current GMP standards as well as international regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production procedures quality products, as well as conformity with the requirements of the CMC Regulatory Compliance for Pharma and EU EMA. Australia TGA and China NMPA are also met. Yaohai BioPharma successfully passed an in-person audit conducted by a Qualified Person of the European Union (QP) to examine our GMP system and production facility. We also completed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• Robuste Lieferkette und Fertigungskapazitäten

  Yaohai Bio-Pharma, a top 10 producer of biological products, is a specialist in microbial fermentation. We have established an advanced facility that is equipped with modern facilities and strong RD manufacturing capabilities. We have five drug substance manufacturing lines that are in compliance with GMP requirements for microbial fermentation and purification, as well as two fill-finish lines that are automated for cartridges, vials, as well as pre-filled syringes. The available fermentation scales vary from 100L to 500L, 1000L and 2000L. CMC Regulatory Compliance for Pharma for vias are 1ml to 25ml, whereas the pre-filled syringes and cartridge filling specifications cover 1-3ml. Our production workshop is cGMP compliant and guarantees steady supply of clinical samples as well as commercial items. Our plant produces large molecules which are shipped to the globe.

• 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, CMC Regulatory Compliance for Pharma, 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.

Verwandte Produktkategorien

• CMC Regulatory Compliance for Pharma
• CMC-Abschnitt in der Arzneimittelanwendung
• Was ist CMC in der Arzneimittelentwicklung?

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