Regulatory

  1. Key Considerations When Developing Your Combination Product 2/20/2024

    Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.

  2. Navigating Special Regulatory Pathways For Advanced Therapy Development Success 6/12/2025

    Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

  3. Seal-Sensor Technology For In-Line Pouch Seal Inspection 11/16/2021

    PTI is integrating the latest technologies for inspecting pouch seals utilizing a method that inspects and analyzes pouch seals non-destructively. Seal-Scan and Seal-Sensor utilize Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively.

  4. Impact Of Water Activity On OSD Product Potency, Purity, And Bioavailability 11/21/2022

    Explore laser-based headspace analysis, the impact of USP<922> Water Activity on primary packing selection, and the impact of water activity on the potency, purity, and bioavailability of OSD products.

  5. How RTU Solutions Can Meet GMP Annex 1 Requirements 5/14/2025

    EU GMP Annex 1 urges better contamination control. RTU containers help pharma firms reduce risks, cut costs, and streamline aseptic manufacturing with simplified, compliant solutions.

  6. Establishing A Container Closure System 5/13/2026

    As a trusted partner to both established and emerging drug developers, we support the safe, effective containment and delivery of life-saving and life-enhancing medicines.

  7. Combination Products: Navigating Regulatory Strategy, Design Verification 5/19/2025

    Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.

  8. Ensuring Integrity: A Comprehensive Approach To CCI 1/8/2026

    Deterministic CCI testing ensures compliance in packaging. Learn how advanced methods like Vacuum Decay, HVLD, and Helium Leak Detection deliver results aligned with USP 1207 and global standards.

  9. Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing

    Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.

  10. Package Integrity Testing Of Dry-Fill Flexible Packaging With VeriPac FLEX 11/16/2021

    The VeriPac FLEX Systems are available in several configurations to accommodate various package specifications. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics.