INSIGHTS ON REGULATORY COMPLIANCE

  • 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.

  • Inspecting On The Edge – Understanding Punch Tip Wear

    Avoid production quality-related issues by understanding and knowing how to identify the most common causes of punch tip edge wear.

  • Putting The “Process” Into Process Characterization

    Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products.

  • The Case For A Facility Monitoring System

    While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.

  • Optical Rotation And Quality Control

    The optically active pharmaceutical and its mirror image are referred to as enantiomers. While they might possess identical physical properties, their physiological properties can differ dramatically. 

More Insights On Regulatory Compliance

REGULATORY COMPLIANCE SOLUTIONS

  • Reduce Cost And Effort When Servicing Clinical Trials In Canada

    Contracting an in-country clinical depot helps bring costs and timelines under control.

  • Residual Solvents Add Risk To Drug Safety
    Residual Solvents Add Risk To Drug Safety

    Improper handling of residual solvents adds risk to quality and safety. Lack of experience and constrained capacity compound it.

  • Level Measurement: Product Overview For Applications In Liquids & Bulk Solids

    With a broad range of level measuring principles available means that finding the ideal solution is easy. No principle is suited to all application areas. Therefore measuring systems must be selected that work reliably under the conditions of a particular application and, at the same time, meet the economic situations in the future. Endress + Hauser can support you from planning and commissioning through to the maintenance of your measuring point as well as assist you in automation, asset management and the visualization of process data.

  • Stability Testing
    Stability Testing

    With over 14,000 ft2 storage capacity and over 14 ICH and custom conditions, Nitto Avecia Pharma Services has the capability to help design stability studies tailored to product needs.

  • Elemental Impurities Emerge As New Compliance Challenge
    Elemental Impurities Emerge As New Compliance Challenge

    After almost 20 years, FDA issued new guidelines in 2018 for elemental impurities. Despite advanced notice, capacity and capabilities remain limited.

More Regulatory Compliance Solutions