Compliance

WHITE PAPERS AND CASE STUDIES

• Comparative Analysis For Non-IND Sites

  A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.

   

   

• Continuous Flow — An Emerging Alternative

  Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.

• Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

  The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

• PCI Compliance: Keep Your Customers And Business Secure The PCI DSS provides steps to protect organizations, customers, and the card processing system from fraud. The steps include requirements for security management, payment policies, data storage procedures, network architecture, software design, and other payment system measures. Submitted by Heartland
• Demanding More From AI Governance In Drug Safety

  Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

• Overcoming Obstacles To Deliver Critical Autologous Cell Therapy

  See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany

• Expectations On The Pathway To GMP For Gene-Modified Cell Therapies

  Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.

• A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
• TAKE Solutions' Team Announces Conatus Pharmaceuticals The Winner In PharmaReady Best Case Study Contest Recently, TAKE Solutions' PharmaReady team announced Conatus Pharmaceuticals the winner in its best case study contest. Of the numerous award submissions, Conatus won by presenting a detailed look into their search for an eSubmissions solution, including their initial criteria, marketplace comparisons and the end results.
• How ABB's Flow And Digital Technologies Help Bawat With Smarter Ballast Water Compliance

  The International Maritime Organization (IMO) sets strict global standards for ballast water management to prevent the spread of harmful aquatic organisms. For companies like Bawat, a Danish innovator in ballast water management, being able to verify ballast water flow measurements quickly, accurately, and from anywhere in the world is essential.

• Serialization And Traceability Compliance In Pharma And Med Device

  Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.

• A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS System

  CRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.