Clinical Supply Packaging Resources

31. FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies

    FDA requires packaging and distribution systems to protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.

32. Lifecycle Planning For Containment And Delivery Of Biologics Drug Products 6/20/2024

    Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development to set yourself up for future success.

33. Investigational Medicinal Products: Labeling Changes And Their Implications 12/16/2022

    Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.

34. A Supply Chain Management Solution Designed for Clinical Research 8/4/2023

    In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.

35. A Risk-Based Approach To Injectable Combination Product Development 3/14/2023

    Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

36. Cut Through Complexity, Gain Speed, And Get Your Drug To Patients ASAP

    Discover top challenges that emerging biologics face, packaging containment offerings and services that help mitigate risks, and ways to reduce obstacles that slow development.

37. IQVIA Labeling Compliance Solutions 5/16/2023

    Learn how by having a strategy for “core-to-carton” compliance, drug developers can avoid risks for patients and their company.

38. GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm 8/15/2023

    Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.

39. The Dual Sourcing Approach 11/17/2022

    Having a secondary supplier in place for the manufacturing and packaging of life-saving critical medicines should be an essential part of your strategy in terms of patient health.

40. Benefits Of Electronic Labels: Investigational Medicinal Products 12/2/2022

    When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, learn why a label must be on its packaging that provides relevant and important information.