INSIGHTS ON REGULATORY COMPLIANCE

• New Guidelines For Container Closure Integrity Testing

  Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.

• What You Need To Know About Process Characterization And Validation For Biologic Processes

  Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.

• 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.

• Key Considerations For A Successful EU Orphan Drug Launch

  During this interactive webinar, the speakers involved will utilize their experience to guide you through the EU product launch process, from submitting your Marketing Application (MA) to final distribution of drug product to the end-user.

• 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.

• CCI Test Method Validation For Pre-Filled Syringes

  Regulators are paying closer attention to the proper design of robust Container Closure Integrity (CCI) studies and the validation of CCI test methods. Read how method validation is used to demonstrate sufficient accuracy and reproducibility of a method, in this case to detect CCI defects at the plunger seal of a pre-filled syringe.

• Why Invest In Emerging Markets Now

  Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?

• 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.

• Developing A New Biologic Drug: Regulatory Challenges And Considerations

  The journey from research lab to market is a long one, and most drug candidates do not make it. Following are some tips to assist with up-front planning to prevent headaches down the road.