Regulatory Compliance Featured Articles

  1. 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.

  2. Best Practices In FDA Orphan Drug Submissions

    A common misconception in the industry is that an orphan designation is one of the easier regulatory milestones to reach. The guidance the FDA has issued on obtaining an orphan designation is relatively straightforward, perhaps so much so that it is easy to overlook some of its key elements.

  3. The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  4. Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance

    A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.

  5. Are These 3 Fear Factors Holding You Back From Regulatory Compliance?

    In the TV series Fear Factor, contestants had to overcome various challenges that most of us found disgusting and/or frightening in order to win a large cash prize. If they failed, their hopes were gone and the contest ended for them. The same can be true for the pharmaceutical industry in trying to achieve the “prize” of being found compliant when audited.

  6. Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies

    This article explores some of the policy changes happening now in the regulatory rare disease space as the FDA’s leadership team implements these changes at the agency.

  7. 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.

  8. State Of Serialization: Where FDA & The Pharma Industry Currently Stand

    For the Drug Supply Chain Security Act to be effective, it requires pharma to institute electronic, interoperable systems that enable stakeholders to identify and trace drugs distributed into the U.S. 

  9. 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.

  10. 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.