INSIGHTS ON REGULATORY COMPLIANCE

• Critical Considerations About The Future Of Global Cell Culture Bioprocessing

  In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

• Complimentary Workshop: EU Product Launch - Key Timeline Milestones From PhIII To Launch

  Launching a product into Europe but unsure about the different requirements for a European market? Join our experts in September at our EU Product Launch Workshop series: Key timeline milestones from phase 3 to launch, where they will guide you through an EU product launch.

• Avoiding HPAPI Contamination

  Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes and deploy appropriate containment strategies. 

• 6 Regulatory Changes Affecting Bioprocessing In China

  This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

• Collaboration In Biopharma: Harness Cloud-based Technologies

  Although biopharma has been slower than some other industries to adopt cloud-based technologies, the field is increasingly relying on the cloud to advance scientific knowledge.

• Improve Sterility Assurance And Data Integrity In A 503B Compounding Pharmacy

  Implementing automated technologies and robotics could be the solution 503B compounding pharmacies need to overcome growing issues with sterility and data integrity.

• Raman Spectroscopy Beyond The Lab: From Loading Dock To Production

  Raman spectroscopy offers a wide range of benefits in industrial and academic research, helping drive profitability in development, research, and quality control.

• Container Closure Integrity Testing Method Development

  Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

• Container Closure Integrity Testing Of Sterile Injectable Product

  This article summarizes the current state of container closure integrity testing in the pharmaceutical and biopharmaceutical industries and outlines possible approaches for developing a CCIT strategy.