Regulatory Compliance Featured Articles

  1. Steering Clear Of The Big Four

    With new regulations having established a need for the testing of certain elements correct sample preparation is crucial.

  2. Optical Rotation And Quality Control

    Quality control testing for enantiomers to ensure the correct pharmacological effect of a drug.

  3. Excipients And SAXS: The Detection Of Structural Aging

    A solution to obtain structural information quickly for effective quality control of pharmaceuticals during production or to study ageing effects and other properties.

  4. Business and Cultural Considerations When Managing Clinical Supplies for Asia-Pacific Studies

    In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

  5. Navigating The Marketing Authorization Process In Europe

    To be able to market a medicinal product in Europe, you must obtain a Marketing Authorization (MA) from the relevant regulatory authority. There are a number of different routes to apply for an MA.

  6. Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities

    This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.

  7. Understanding And Delivering Your EU Orphan Drug Launch

    Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.

  8. Solving The OOS Problem With Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.

  9. Autologous Cell Therapies At Crossroads With FDA: What To Do Now?

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?

  10. How To Prepare For Chamber Mapping In Life Sciences — 8 Critical Steps

    A failed chamber mapping study can lead to unnecessary costs in valuable biopharmaceutical production time or regulatory and product quality issues.