Regulatory Compliance Featured Articles

  1. Collaboration In Biopharma: Harnessing The Power Of Cloud-based Technologies
    7/8/2019

    From banking to e-commerce, cloud computing has transformed the landscape of the world economy. It is also gradually changing the face of the biopharma industry. In the scientific world, effective communication and collaboration are essential to successful outcomes. Although biopharma has been slower than some other industries to adopt cloud-based technologies, the field is increasingly relying on the cloud to advance scientific knowledge.

  2. An Analysis Of 2018 FDA Warning Letters Citing Data Integrity Failures
    6/12/2019

    FDA enforcement for failures in data integrity and data governance began almost 20 years ago, and these areas remain as enforcement initiatives of the FDA and other global health authorities to this day.

  3. The Current Landscape For Developing Biosimilars In India
    6/2/2019

    As India’s biosimilar market moves toward a promising future, it is important to gain an overview of the current regulatory and clinical expectations in India for biosimilar products.

  4. Raman Spectroscopy Beyond The Lab: From Loading Dock To Production
    5/13/2019

    Raman spectroscopy offers a wide range of benefits in industrial and academic research, helping drive profitability in development, research, and quality control.

  5. To Err Is Human: Contextual Communication’s Impact On Data Integrity
    5/8/2019

    Despite the best efforts of those responsible for data integrity, the potential for human error is directly and indirectly impacted by the corporate, the national/regional , and quality culture of an organization.

  6. An Intro To Adverse Event Reporting And Product Complaints
    4/23/2019

    Managing complaints and controlling adverse events are critical tasks for a pharmaceutical company. While varying international regulations for adverse event reporting and product complaint handling make it difficult to automate processes and implement SOPs, it is necessary for companies to successfully resolve incidents and continue on a path to innovation.

  7. Inside FDA's Proposed Program To Establish Voluntary Quality Standards
    4/17/2019

    The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality.

  8. What Should You Do After An FDA Inspection?
    3/29/2019

    The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.

  9. Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?
    3/27/2019

    Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

  10. Pharma Industry Braces For A No-Deal Brexit
    3/22/2019

    Chaos reigns supreme in London at the moment, as British Prime Minister Theresa May struggles to find a graceful way for the United Kingdom to exit from the European Union (EU). Meanwhile, pharmaceutical manufacturers must prepare for multiple potential outcomes, including a “no-deal” (or “hard”) Brexit.